Job Title: Principal Combination Product Quality Engineer
Are you someone who is interested in joining an innovative, niche and talented Biopharmaceutical company? My client is paving the way with a Nobel-prize winning technology to target four different therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases and CNS/ocular diseases. Another unique component of my client is the company culture - named one of the Top Places to Work in Boston six years in a row. If you are someone with excellent communication, organizational and interpersonal skills, this may be the opportunity for you!
The Principal Combination Product Quality Engineer will be responsible for:
- Providing technical quality support for design changes, design-related continuous improvement efforts, market expansions, root cause investigations, CAPA and Change Controls.
- Lead and support updates for combination product design history, human factors and risk management file.
- Act as a liaison with External QA in provision of quality oversight for contract manufacturers.
- Lead and support combination product regulation processes, product driven QMS efforts and represent combination product teams on Corporate QMS initiatives.
- Support design control internal audits, notified body audits and regulatory inspections.
- Provide combination product QA expertise for Finished Good/Packaging activities.
The Principal Combination Product Quality Engineer should have the following qualifications:
- Bachelor's Degree in Engineering or Sciences.
- At least 10 years of device and/or combination product cGMP experience with at least 5 years in a Quality Assurance/Engineering role.
- Understanding of Device and Combination Product regulations, standards and guidelines (21 CFR Part 4, Part 803, ISO13845 etc.)
- Preferably working knowledge of Pre-Filled Syringe and Autoinjector technical standards (ISO11040, ISO11608 etc.)
- Providing in-clinic or on-market product Quality Assurance support.
- Maintaining design history, human factors and risk management files throughout the product life-cycle.
- Providing quality oversight of external partners and vendors including external audits and authoring quality agreements.
- Translate and implement evolving regulatory requirements into a corporate QMS.
- Preferably ASQ or CQE certifications.
If this sounds like something that you would be interested, do not hesitate to apply!