Quality Engineer
Department: QA/QC
Company Overview
Quantimetrix, located in Redondo Beach, California, is a company that designs, develops, and manufactures clinical laboratory quality controls. For nearly 50 years, we have delivered industry-leading products and services to the medical community.
We are seeking a highly qualified Quality Engineer to join our Quality Assurance team of engineers. In this role, you will apply Quality Assurance and Quality Engineering principles to ensure compliance with regulatory requirements and support systems that optimize product design and manufacturing processes.
This position involves writing, reviewing, and approving validation and verification protocols for equipment, systems, and manufacturing processes, as well as supporting qualification and requalification activities. The ideal candidate is detail-oriented, able to work independently with minimal supervision, and collaborates effectively within cross-functional teams to ensure compliance with applicable regulations (FDA QSR, ISO 13485, MDSAP, IVDR, and Health Canada).
What You'll Do
- Apply Quality Assurance and Quality Engineering principles to ensure compliance with regulatory requirements
- Support and improve systems that optimize product design and manufacturing processes
- Write, review, and approve validation and verification protocols for equipment, systems, and manufacturing processes
- Lead and support qualification, requalification, and verification activities
- Ensure compliance with applicable regulations including FDA QSR, ISO 13485, MDSAP, IVDR, and Health Canada requirements
- Collaborate with cross-functional teams to drive quality and compliance initiatives
- Work independently with minimal supervision while managing multiple priorities
- Develop, write, and support validation protocols and studies (IQ, OQ, PQ), including design validations (prospective and retrospective)
- Compile, analyze, and assess data for validation and qualification reports, including statistical sampling justification
- Provide guidance to team members on validation protocol development and sampling rationale
- Lead or support test method development and validation for new and existing products
- Author and revise SOPs, work instructions, and documentation supporting QA/QC processes
- Contribute to Product Technical Files for IVDR registrations
- Conduct or support investigations related to non-conformances, product failures, and root cause analysis (including FMEA and risk assessments)
- Develop and revise raw material/component specifications, including sampling plans and inspection strategies (e.g., skip lot, dock-to-stock)
- Analyze test data, perform computations, and provide recommendations
- Review data for accuracy, consistency, and compliance
- Perform QC laboratory testing to support new product development
- Conduct trend analysis and generate periodic reports
What We're Looking For
- Bachelor's degree in Life Sciences, Engineering, or a related field
- 5+ years of experience in the medical device or IVD Medical Device manufacturing industry, with a strong background in validations and/or quality engineering
- Experience in Quality Assurance, including the practical application of FDA Quality System Regulation (QSR)and ISO 13485
- IVDR experience is a plus
- Strong ability to write detailed technical reports and validation studies
- Proficiency in data analysis and presenting results in a clear, scientific manner
- Advanced skills in Microsoft Excel and statistical analysis
- Strong written and verbal communication skills
- Experience with quality tools (e.g., FMEA, Pareto charts, histograms, SPC, flowcharts)
- Demonstrated experience in technical documentation and statistical data analysis
- Knowledge of Risk Management and Design Controls
- Ability to collaborate effectively across cross-functional teams
- ASQ Certified Quality Engineer (CQE) or other ASQ Quality Engineering certifications are a plus
Compensation
The salary range for this position will be $85,000 - $95,000 and will be determined based on experience, skills, education, certifications, and location
Benefits
- Medical, dental and vision benefits
- Life insurance
- 401K match
- FSA
- PTO
- Educational assistance program
- Employee Discounts provided through PEO
- Employee Assistance Program
Apply now and help us bring our products to patients worldwide! Send your resume to hr@quantimetrix.com.
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Regulatory Affairs Specialist