Staff Quality Engineer

Job DescriptionJob DescriptionSalary:
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Position Description

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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.

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Responsibilities

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• Function as Lead Quality Engineer to support Product Development design controls by ensuring hardware and software design meet compliance standards
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• Review test protocol requirements, drawing specifications and tolerancing, test results, risk management matrices, quality plans, and documents associated with Design History Files
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• Determine verification and validation testing strategies of design changes to ensure product integrity and specifications requirements are met
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• 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
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• Collaborate and build partnerships with key suppliers. Monitor and evaluate supplier metrics to identify trends
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• Identify and implement cost reduction activities
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• Update Standard Operation Procedures to aid in the development of a robust and compliant Quality Management System; train staff on SOP updates.
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• Support Non-conformance and CAPA program by leading investigations, root cause, and corrective action implementation plans
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• Support site during external audits (Notified Body, FDA)
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• Perform other job duties as assigned by management
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Qualifications

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• Education: Bachelors degree in engineering, mechanical engineering or related field, or equivalent work experience
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• Experience: 10+ years of regulated medical device quality experience required preferably with expertise in GMP, QMSR, ISO 13485, MDD/MDR regulations.
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• Working knowledge of test method qualification, (Gage R&R, Attribute Agreement Analysis), Statistical Process Control (SPC), Design of Experiments (DOE), probability and statistics
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• Strong knowledge of process validation (IQ,OQ,PQ), risk management per ISO 14971 and Design Control requirements.
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• Proficient with investigational tools such as 5-Whys, Fishbone Diagram, etc.
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• Experience with spine or orthopedics is a plus
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• Experience in software quality is a plus
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• Certification: ASQ CQA, CQE, Six Sigma Green/Black Belt is a plus
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Skills

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• Excellent verbal and written communication
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• Ability to perform high quality work with speed
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• Willingness to wear multiple hats when needed to enable excellent patient outcomes
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• Self-directed, able to find answers
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Equal Opportunity Employer

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Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to , , , , , , , veteran, or 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 , please let us know.

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Compensation

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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.