Senior Quality Assurance Specialist - Medical Device
Job Description
Job Description
A-Line Staffing is now hiring a Senior Quality Assurance Specialist – Medical Device in San Diego, CA 92154.
The Senior Quality Assurance Specialist will be working on-site at a leading medical device manufacturing facility and has strong potential for long-term employment. This is a full-time opportunity, 100% on-site, Monday through Friday.
If you are interested in this Senior Quality Assurance Specialist – Medical Device position, please contact Lindsay at 586-710-7959 or LKOPASZ@alinestaffing.com
Senior Quality Assurance Specialist – Medical Device Compensation
• The pay for this position is $41.67 per hour
• Benefits are available to full-time employees after 90 days of employment
• A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates
Position Highlights
• This position is a contract assignment with potential to hire on permanently based upon attendance, performance, and business needs
• This is a 100% on-site position, located at 2600 Melksee Street, San Diego, CA 92154
• Schedule: Monday–Friday, standard day shift
Job Summary
The Senior Quality Assurance Specialist is responsible for providing quality assurance support for the picking, relabeling, and repacking of BDB finished goods prior to shipment. The role partners with cross-functional teams to ensure product quality and timely delivery in a regulated medical device manufacturing environment.
Key Responsibilities
1. Quality Assurance Activities
• Review, sign off, scan, and store daily batch and line clearance records for reagent repack/relabel (RR) processes
• Manage RR verifier qualification program documentation
• Scan, upload, and store QMS records (EMS reports, training records, validation reports, etc.) per retention policies
• Address discrepancies in material master data and manufacturing batches
• Manage the ABI-OEM material program, including quarantine, sampling, inspection coordination, and product release
• Initiate and support nonconformance reports (NCMRs) or quality notifications (QNs), assist with root cause investigations, and implement corrective actions
• Physically and systemically manage nonconforming inventory using SAP, maintain MRB cage material logs
2. Validation
• Perform equipment IQ/OQ under the supervision of a Staff Quality Engineer or designee
3. Training
• Maintain personal training compliance
• Support training for junior QA staff and cross-functional team members
4. Quality Metrics
• Collect and analyze quality data, generate trending charts, and contribute to quality system reviews and management reviews
5. Additional Responsibilities
• Communicate quality issues and product release concerns from the production floor
• Follow Environmental Health & Safety (EHS) policies and actively participate in safety initiatives
• Collaborate with internal stakeholders including Operations, R&D, Planning, Quality Engineers, and Logistics
• Perform other related duties as assigned
Requirements
• Bachelor’s degree in Science, Engineering, or a related discipline
• Minimum of 7 years of relevant quality experience in a regulated industry (medical device, diagnostics, or life sciences)
• High School Diploma or GED
• Attendance is mandatory for the first 90 days
Preferred Qualifications
• Strong background in Inventory Allocation and Supply Planning
• Proficiency with Excel (pivot tables, formulas, large data sets)
• SAP experience is required
• Familiarity with ISO 9001, ISO 13485, and applicable regulatory standards
• Self-driven, detail-oriented, and able to manage tasks independently
• Strong analytical, communication, and organizational skills
If you think this Senior Quality Assurance Specialist – Medical Device position is a good fit for you, please reach out to me – feel free to call, e-mail, or apply to this posting!
If you are interested in this Senior Quality Assurance Specialist – Medical Device position, please contact Lindsay at 586-710-7959 or LKOPASZ@alinestaffing.com