Quality Systems Engineer
About The Position
MP Biomedicals is a global life science company headquartered in California, with regional offices around the world. Its portfolio includes life science products, fine chemicals, and diagnostics for applications ranging from basic research to clinical diagnostics and pharmaceuticals. The company’s mission is to empower global research that unlocks life-changing solutions and inspires a meaningful life. The Quality Systems Engineer coordinates and leads activities related to the ISO 9001 and ISO 13485 quality systems and improves and maintains the documents needed to support them. The role participates in quality activities for both the Life Science and Diagnostics sections, working with operations, Quality Control, customers, suppliers, auditors, and inspectors to support compliance and continual improvement.
Requirements
- Bachelor’s degree in engineering, science, or technical studies.
- 1–3 years of relevant experience.
- Experience with Quality Management Systems, including ISO 9001 and ISO 13485.
- Experience with Quality System Regulation (21 CFR 820).
- Quality and compliance audit experience.
- Corrective and Preventive Action (CAPA) experience, including applying root-cause analysis tools to nonconformance investigations.
- Process and product change-control experience.
- Strong verbal and written communication, critical-thinking, interpersonal, organizational, time-management, and presentation skills.
- Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
Responsibilities
- Coordinate and investigate quality-related customer complaints.
- Participate in customer audits, ISO certification and recertification activities, and internal audits.
- Prepare reports and required documentation; coordinate monthly CAPA meetings and prepare meeting minutes.
- Coordinate and participate in supplier qualification and supplier change control.
- Prepare customer questionnaires, forms, and other quality-related documents.
- Work directly with operations and Quality Control to provide ongoing process-analysis oversight, enforce requirements, and meet regulations.
- Lead audit and inspection preparation, resolution of findings, and communication with auditing groups and inspectors throughout the audit process.
- Continuously improve potential deficiencies in the quality management system through internal and external auditing.
- Analyze data for metrics reporting, performance against established plans, and root-cause and risk analysis.
- Cross-train across related functions to support operational flexibility and team coverage.
- Maintain a foundational understanding of this and similar roles to provide support during staff absences, peak demand, or special projects.
- Perform other assigned duties and additional responsibilities needed to support the department and organization.
Benefits
- Bonus pay
- Monthly childcare credit
- Free breakfast on Mondays
- Free catered lunches Tuesday through Friday
- Paid vacation
- Paid PTO hours
- 10 paid company holidays per year
- 401(k) with company match
- Competitive healthcare benefits
- Health Savings Account (HSA)
- Company-paid life insurance and short-term disability
- Learning and Development Program
- Employee Referral Program
- Employee Assistance Program
- Employee discounts
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
