Sr. Quality Assurance Engineer - Medical Device

Job Type

Full-time

Description

The opportunity:

Arsenal Medical is a clinical-stage company that creates innovative biomaterials to solve challenging and underserved medical problems. Our lead products target neurovascular and trauma conditions.

We have a job opening for a hands-on, full-time Senior Quality Assurance Engineer. This person must thrive in a fast-paced environment, be able to work on multiple product development and quality projects simultaneously and be motivated by the opportunity to learn and make an impact in the organization. This is a unique role combining engineering design assurance and quality skills.

Key areas of responsibility:

Quality Assurance

Represent all aspects of Quality to ensure programs meet quality standards, as well as design control and regulatory requirements

Develop, implement, and execute quality management systems (equipment, training, documentation, supplier management, including e-QMS, etc.) to support business needs

Quality Representative for project teams (risk management, design verification, qualifications/validations, clinical product batch release, and other related PDP tasks) Design Assurance

Support internal/external manufacturing of our products including incoming inspection, QC testing, data analysis/trending, and reporting

Lead investigations related to design, process or testing issues

Collaborate with cross functional teams to ensure the quality and safety of our products Requirements

Minimum BS in Engineering or Science or related discipline

Prefer 4+ years' Quality experience in medical devices or combination products

Strong knowledge of the US and International standards governing the design, development, and manufacture of medical devices

Experience with ISO 13485, ISO 14971, GMP CFR 820, and applicable ICH guidelines is preferred

Excellent written, data analysis, presentation skills

Mostly on site with occasional remote work

Occasional domestic travel

Arsenal Medical, Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. We will consider all qualified applicants for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected class.