Join a top-tier global biotech leader in San Diego, CA, as the primary quality lead on cross-functional development teams. This full-time, on-site role is ideal for a collaborative technical expert with deep specialization in plastics and injection molding seeking to impact life-saving device manufacturing.
location: San Diego, California
job type: Permanent
salary: $130,000 - 150,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Serve as Subject Matter Expert (SME) in injection molding and plastics, evaluating designs, specifications, and device compatibility.
- Lead supplier risk management, qualification programs, and annual supplier audit schedules using a risk-based approach.
- Drive root-cause investigations for material issues, execute Vendor Notifications, and manage SCAR closures.
- Oversee supplier performance metrics, quality agreements, and raw material specification approvals.
- Represent Quality Assurance on special projects and support regulatory audits (FDA, notified bodies).
qualifications:
Required:
- SME-level knowledge in plastics and injection molding (design compatibility, specifications, and manufacturing quality).
- 5+ years of supplier management experience in a regulated industry (FDA/Pharma/IVD/Medical Device preferred; Aerospace or Nutraceuticals considered).
- Bachelor's degree in Biomedical Engineering, Chemistry, Biology, or related field with 8+ years of QA experience (or 12+ years of experience with a High School Diploma).
- Demonstrated expertise in root-cause analysis, SCAR management, and supplier auditing.
- Hands-on experience with electronic document management systems (eDMS).
- Experience with SAP and statistical software for trend analysis.
- Prior experience hosting third-party or FDA regulatory audits.
skills: Quality Assurance (QA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
