Quality Engineer II - Hybrid
- Posted: over a month ago
Provide Quality Engineering support to commercial manufacturing at Access Vascular. This is a collaborative position working closely with Operations, NPI and R&D to ensure compliance with AVI's QMS, and FDA QSR requirements.
Duties & Responsibilities
- As a Quality Engineer, support all aspects of Quality and Operations, including, but not limited to, the following Quality Management Systems:
- Complaint / Medical Device Reporting (MDR)
- Supplier Quality
- Equipment and process validation
- Identify and lead Quality System continuous process improvements.
- Lead cross-functional teams in the implementation of process risk management activities
- Core team member on Change Control projects
- Interface with manufacturing, NPI Engineering, Research and Development, and other Quality team members to ensure effective design transfer to manufacturing
- BS in related technical field, preferably Engineering
- 3-5 years of quality engineering experience in the Life Science or Medical Device Industries
- Working knowledge of 21 CFR 820, ISO 13485 and ISO 14971
- Teamwork, flexibility and adaptability to change
- Ability to review and write technical documentation
- Self-initiator with strong organization skills
- Ability to communicate and lead through influence
Conditions of Employment:
Candidates will be required to show proof that they are fully vaccinated against COVID-19 prior to commencing employment. For purposes of this requirement, "fully vaccinated" shall have the then-current meaning ascribed by the US Center for Disease Control and Prevention (CDC). Exemptions from this requirement as a reasonable accommodation will be considered on a case-by-case basis in accordance with applicable law.
Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and are capable of long-term thrombus resistance and infection protection.
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