OriGen Biomedical Open Jobs

Director of Quality Assurance and Regulatory Affairs in Austin, TX

Located in Austin Texas, we are a well-established, fast-growing, medium size medical device company specializing in devices for cryopreservation and cell culture. We are currently looking for an experienced Quality Assurance and Regulatory Affairs (QA/RA) Director to join our team.

Position Summary

The Regulatory Affairs Director is responsible ensuring compliance with global medical device regulations including CFR, ISO 13485 and MDSAP requirements. This position will manage both the Regulatory and Quality staff.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Develops a forward-looking compliance program to maintain global distribution of medical devices.
• Advocate for and work within a medium size device firm.
• Ensures that the Quality System requirements are established and maintained as described in applicable FDA and International Standards.
• Provide clear and concise reporting on QA and RA functions.
• Technical writing, direction and submission of Regulatory documentation.
• Manage and improve the Quality function through direct report supervisors.
• Oversees Quality Assurance functions, including
  • All internal and external audits
  • CAPA, complaints and MRBs
  • Supplier assessment
  • Training programs
  • Design control
• Maintains and updates Technical Files on company’s devices.
• Works with other departments to integrate Regulatory and Quality requirements into all processes.
• Assists our Distributors in meeting local regulatory requirements.
• Leads their team to achieve deadlines on time and on budget.
• Participates in all phases of Product Design.
• Participates in Strategic Planning.

Competencies

• Proven Leadership Skills
• Intimate knowledge of Regulatory environment for medical devices, CFR, 13485. MDR
• Cost conscious, small company attitude
• Excellent communication and interpersonal skills
• Superior organizational and time management skills
• Sound decision making
• Ethical Conduct
• Close attention to detail
• Broad creativity and curiosity
• Effective problem-solving skills
• Adaptability, can work with changing priorities

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree in Science/Math/Engineering
• 10+ years’ experience in QA / RA in medical device manufacturing
• 5+ years of leadership experience
• 4+ years’ recent experience in CFR / ISO 13485 environment
• Audit experience with FDA and Notified Bodies
• Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
• Ability to work independently and lead in a team environment

Preferred Qualifications

• Masters’ degree in a related discipline
• Professional certification preferred (ASQ CQA, CQE, C Q. Mgr, CQA-Biomedical, RAC)

Supervisory Responsibility

This position supervises of a department of ten and growing.  The individual may also be required to lead project teams and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Position Summary

The IT Engineer is responsible for maintaining and upgrading computer hardware and software systems.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Provides User support on hardware and software
• Does Network repairs, upgrades and troubleshooting
• Technical writing
• Work in a highly regulated industry
• Administration and support of Salesforce platform and Epicor ERP system
• Administration and maintenance of Windows Active Directory and SQL Server
• Creation and support of reports in SQL Server Reporting Services
• Provides support for site security policies and processes, including but not limited to developing policies for successful implementation across the business (both physical and cyber-security)

Competencies

• Experience with SQL databases
• Good interpersonal skills

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree in Computer Science/Math/Engineering
• Ability to understand and interpret customer needs; ability to work with all departments (i.e. Regulatory, Operations, Human Resources, Engineering)
• Ability to work independently and lead in a team environment

Preferred Qualifications

• Experience with Epicor ERP software suite
• Experience with Salesforce/BarTender/SQL Server

Supervisory Responsibility

This position has no direct supervision. The individual may also be required to lead project teams and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 60 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal but there may be increased noise or fumes in the warehouse and/or shipping and receiving areas.

Salary:

Position Summary

OriGen is seeking a technician with solid electro-mechanical skills to be responsible for the range of manufacturing equipment used in the production of our products. Someone with good mechanical skills, excellent ability with hand tools, some understanding of DC analog circuits, and the ability to troubleshoot and repair a range of electro-mechanical production equipment. Must have a good grasp of current metrology practices, calibration, and use of measuring instruments. Will be responsible for setup and qualification of production systems.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Engineering activities include:

• Installation, qualification, maintenance, setup, and calibration of production systems and equipment
• Monitor and adjust production processes or equipment for quality and productivity
• Assist engineers in developing, building, or testing prototypes, processes, or procedures
• Perform preventative maintenance
• Assist with 5S activities
• Help identify necessary improvements to processes, equipment, supplies and/or tools
• Technical skills in interpreting drawings and written procedures
• Able to troubleshoot issues with equipment, both electrical and mechanical
• Understanding of GMP and ISO requirements a plus

Skill set

• Knowledge of FDA regulations and GMP guidelines for medical device process validation.
• Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
• Works in cross functional teams to complete projects and testing.
• Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel.
• Will be required to write reports and log data in Microsoft Word and Excel.
• Will develop and check written procedures for setup, test and general operations of production equipment.
• Will draft protocols and reports for minor validation activities. Written communication with vendors will be required
• Outstanding communication skills, both written and oral, and will be expected to communicate directly with production  management, production technicians, engineers, and senior management.
• Will be required to train and/or validate training of production staff on operation of production equipment.

Competencies

• Self-motivated
• Broad creativity and curiosity
• Problem-solving skills
• Project Management
• Ethical Conduct
• Communication and interpersonal skills
• Strategic Thought
• Adaptability
• Validation testing
• Decision making
• Corrective and preventative actions

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree or 2+ years’ experience in an engineering position in life sciences industry
• Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; strong troubleshoot ability
• Strong interpersonal and people skills
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Strong and effective communication skills (verbal and written)
• Close attention to detail
• Ability to work independently and lead or participate in a cross-functional team environment

Preferred Qualifications

• Bachelor’s degree in Engineering
  • Preferred: chemical, biomedical, or mechanical
• ISO 13485 experience

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and
ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such
as computers, phones, photocopiers, filing cabinets and fax machines.

This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear
personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and
gloves.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to
successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations
may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee
is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is
occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift
and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance
vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Position Summary

The Quality Engineer is responsible for technical duties within the Quality organization including validation and qualification,  calibration, and customer contact. These duties will support manufacturing operations, customer service, process improvement, and  regulatory requirements.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Run technical programs within the Quality department, including calibration, sterilizer qualifications and clean room qualifications.
• Plan and coordinate problem solving, validation and verification.
• Technical writing to include document development and review.
• Assists with complaint investigation and follow up required directly with customer.
• May be required to train and direct others.
• Assist with technical writing to support regulatory submissions.
• Develop Root Cause Analysis on problems originating from all sources, from production to end-user.
• Other duties and/or projects as assigned.

Competencies

• Self-starter
• Good math, technical writing and computer skills
• Close attention to detail
• DOE and validation testing
• Familiar with quality tools and procedures
• Broad creativity and curiosity
• Organizational and time management skills
• Good math, technical writing and computer skills
• Seasoned problem-solving skills
• Ethical Conduct
• Communication and interpersonal skills
• Can work with changing priorities
• Adaptability
• Results-driven
• Decision making

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree in Engineering, or equivalent
• Haas previously worked or interned experience in medical device quality / ISO 13485 environment
• Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; hands-on troubleshooting ability
• Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
• Ability to work independently and lead or participate in a team environment

Preferred Qualifications

• 2-5 years’ experience in medical device quality / ISO 13485 environment
• 2+ years’ experience in a manufacturing environment

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 5:45am – 2:15pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for: assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Ability to meet production schedules and deadlines according to quality standards
• Ability to work in a flexible and changing environment
• Ability to follow detailed written and verbal instructions
• Ability to learn multiple tasks and train in other areas as needed
• Ability to work with a variety of tools and equipment
• Ability to maintain all logs, paperwork, and forms accurately
• Required to understand, access, and make entries to documents on the company Electronic Document System
• Ability to accurately perform job duties with minimum supervision
• Ability to adhere to cleanroom dress code and policies
• Ability to work in a multi-cultural team environment and be a team player
• Ability to work in a cleanroom environment for extended periods of time
• Punctual and Reliable!!

Required Skill Sets

• Must be detailed oriented and be able to focus on a repetitive task for long periods of time
• Must be proficient on a computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

Competencies

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Basic computer navigation and program knowledge
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Pays very close attention to detail
• Ability to work independently and within a team environment  

Preferred Qualifications

• Prior Clean Room experience preferred

Compensation

Based on experience and ability

If you are interested in working at OriGen, but do not see a current opening that fits your skillset, please use the form below and you’ll be notified if a similar role becomes available.

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