Staff Quality Engineer
Carlsmed
Position Description
As Staff Quality Engineer, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. Occasional travel (up to 10% travel) for this role is required for supplier audits and supplier visits.
Responsibilities
- Function as Lead Quality Engineer to support Product Development design controls by ensuring hardware and software design meet compliance standards
- Review test protocol requirements, drawing specifications and tolerancing, test results, risk management matrices, quality plans, and documents associated with Design History Files
- Determine verification and validation testing strategies of design changes to ensure product integrity and specifications requirements are met
- Function as Lead Auditor with responsibility of executing supplier qualifications and supplier surveillance audits. Responsible for audit plans, audit reports, and resolution of supplier audit non-conformances
- Collaborate and build partnerships with key suppliers. Monitor and evaluate supplier metrics to identify trends
- Identify and implement cost reduction activities
- Update Standard Operation Procedures to aid in the development of a robust and compliant Quality Management System; train staff on SOP updates.
- Support Non-conformance and CAPA program by leading investigations, root cause, and corrective action implementation plans
- Support site during external audits (Notified Body, FDA)
- Perform other job duties as assigned by management
Qualifications
- Education: Bachelor’s degree in engineering, mechanical engineering or related field, or equivalent work experience
- Experience: 10+ years of regulated medical device quality experience required preferably with expertise in GMP, QMSR, ISO 13485, MDD/MDR regulations.
- Working knowledge of test method qualification, (Gage R&R, Attribute Agreement Analysis), Statistical Process Control (SPC), Design of Experiments (DOE), probability and statistics
- Strong knowledge of process validation (IQ,OQ,PQ), risk management per ISO 14971 and Design Control requirements.
- Proficient with investigational tools such as 5-Whys, Fishbone Diagram, etc.
- Experience with spine or orthopedics is a plus
- Experience in software quality is a plus
- Certification: ASQ CQA, CQE, Six Sigma Green/Black Belt is a plus
Skills
- Excellent verbal and written communication
- Ability to perform high quality work with speed
- Willingness to wear multiple hats when needed to enable excellent patient outcomes
- Self-directed, able to find answers
Equal Opportunity Employer
Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.
Compensation
We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected pay range is: $150K to $170K annually. Compensation may vary based on related skills, experience, and relevant key attributes.