What are the responsibilities and job description for the Quality Engineer - Medical Device position at AngioSafe?
Overview: AngioSafe is a Bay Area medical device company focusing on improving healthcare delivery through state-of-the-art catheter development. Our seasoned experts are committed to producing and selling high quality and innovative products to decrease risk and improve outcomes of arterial disease. AngioSafe’s Quality Engineer is responsible for supporting key quality systems, ensuring compliance with internal and regulatory standards, and providing day-to-day engineering support.
Roles & Responsibilities:
- Promote and uphold site safety policies and procedures.
- Support key business metrics by providing Quality Engineering expertise for all applicable processes.
- Conduct root cause analysis for quality issues.
- Perform statistical analysis including ANOVA, DOE, Weibull, GR&R, capability studies, FMEA, and TMV.
- Evaluate, design, and implement inspection and process control systems.
- Assist in validation activities for processes, equipment, software, and computerized systems.
- Prepare and maintain clear documentation including protocols, reports, and procedures.
- Support new product introductions and process transfers.
- Participate in complaint investigations, non-conformances, and CAPA activities.
- Collaborate cross-functionally in quality review meetings.
- Engage in internal/external audits and regulatory compliance activities.
- Provide training and guidance to R&D and Manufacturing colleagues on quality standards and inspection techniques.
- Lead or support continuous improvement and cost-reduction initiatives.
Skills, Experience, Education, & Behaviors:
- Requires a B.S. in engineering or related technical field
- Minimum 2 years of relevant experience in Quality Engineering or a regulated manufacturing environment (Medical Device Required --Catheters Preferred*)
- Knowledge and understanding of ISO 13485:2016 and FDA Quality system regulation requirements
- Experience with inspection planning, control plans, and validation in a regulated environment
- Familiarity with Six Sigma or other structured problem-solving methodologies
- Prior experience participating in audits or regulatory inspections
- Working knowledge of complaint handling, document control systems, and inventory management tools
- Certification in Quality Engineering (e.g., CQE) a plus
- Experience in root cause analysis, process validation, and quality systems
- Strong understanding of quality system regulations and standards
- Proficient in statistical analysis tools and techniques
- Demonstrated ability to work independently and with inherent initiative
- Flexibility and willingness to take on a variety of roles in a small company
- Strong decision-making, organizational, and problem-solving abilities
- Demonstrated ability to collaborate effectively across teams
- Strong verbal and written communication skills
- Proficiency with Microsoft Office & quality management software; experience with MasterControl a plus
AngioSafe offers competitive compensation and benefits. Pay for the successful candidate will depend on various factors (e.g. qualifications, education, prior experience).
Benefits:
- Medical, Dental, Vision, & Life
- Paid Time Off Holidays
- Hybrid work environment (role dependent)
- 401K
- Company Equity
Principals only Please
Company Information
AngioSafe is committed to a diverse workplace and is committed to equal opportunity employment for all job applicants without regard to race, color, religion, sex, sexual orientation, age, gender, gender identity or expression, size, national origin, disability, or veteran status. AngioSafe complies with all applicable local, state, and national laws governing non-discrimination in employment.
AngioSafe will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager.
Salary : $75,000 - $125,000
