QA Specialist II
Be part of something altogether life-changing! Working at Biomeme in the Biotechnology industry means being at the forefront of providing healthcare diagnostic technology that empowers anyone, anywhere.
Who we are looking for…
Biomeme is seeking a QA Specialist II who will be responsible for actively supporting the development, implementation and monitoring elements of the Quality Management System. This position is responsible for managing complaint handling and provides quality oversight of production paperwork to ensure that products released meet the quality, integrity, and efficiency standards set by the organization.
What you will do…
- Promptly and accurately review daily production paperwork and ensure manufacturing batch and device history records are complete and meet product release requirements.
- Ensure all quality records are maintained per procedures.
- Liaise with Customer Success team members in product complaint investigations leading to root cause.
- Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
- Review product complaint investigation reports based on accuracy and relevancy to the issue.
- Maintain risk management documentation post-launch and update as required per post-market surveillance/vigilance obligations.
- Facilitate meetings and escalations.
- Maintain and revise applicable processes.
- May perform QA review and approval of product labeling
- Involved in projects that drive improvements to the quality system and support individual department continuous improvement goals.
What you bring to the table…
- B.S. degree in life sciences or related technical field
- 2-5 years professional experience in quality (or related functional area) in medical device industry
- Experience with medical devices is required
- Working knowledge of 21 CFR 820 and ISO 13485
- Ability to effectively communicate
- Excellent analytical and problem-solving skills
It would be great if you have…
- Experience with in vitro diagnostic devices strongly preferred.
- Knowledge of problem-solving techniques (Root Cause analysis, Fault Tree analysis, 5-whys, etc.)
Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3) Biomeme is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
