Quality Assurance EngineerDepartment: Quality
Employment Type: Full Time
Location: Burlington, MA
Compensation: $85,000 - $100,000 / year
DescriptionWhat we're looking for:The Quality Assurance Engineer (QAE) supports the New Product Development (NPD) team, working cross-functionally to support various Quality activities including design controls, V&V planning, QA test development, and application/execution of the QMS. This role specializes in QA vs. QC, requiring familiarity with the Medical Device Product Development process. (PDP)
Our ideal candidate is a well-organized, process-oriented, and systematic-minded professional who is able to keep an eye toward process improvements and innovation. Keys to success in this role include strong attention to detail as well as the capability to both collaborate effectively and work independently.
How You'll Drive Impact:- Hands-on test development and qualification, along with participation in design reviews, design verification, and validation testing.
- Participate in the development, review, and approval of quality documentation including SOPs, work instructions, specifications, and protocols.
- Evaluation and processing of design change qualifications, assisting with the development of product specifications.
- Risk evaluation and assessment, including data collection and statistical analysis as well as review of Engineering protocols and reports.
- Composition and submission of protocols and reports if applicable, as well as other QMS or other Quality-related responsibilities as assigned.
- Provision of guidance to more junior Quality team members as appropriate.
- Support Product Development Life Cycle from concept through production.
- Participate in risk management activities including review failure mode effects analysis (FMEA).
- Collaborate with the team to drive Quality improvement projects and corrective and preventative actions (CAPA).
What You'll Bring:- 2-3+ years' professional experience in QA or similar with medical device industry experience, ideally in new product development. (NPD)
- Electromechanical device development and testing experience.
- Prior background with and knowledge of Quality Management Systems. (QMS)
- Bachelor's degree in Biomedical Engineering or related field.
- Former experience with and ability to apply statistical analysis tools.
