Quality Assurance Technician (Must Have ISO 13485/9001 Exp)

Location: San Diego, CA • Duration: 8 months • Hours: 40/week • Pay rate: $20–30/hr • Shift: 7 AM–4 PM or 8 AM–5 PM • Employment type: Contract (W2) • Eligibility: US citizens or green-card holders only

About the role

Quality associates support the development and implementation of programs to establish and maintain quality standards for existing products and services, as well as developing initiatives to focus employees on quality improvement. The QA Technician oversees and maintains in-process and final inspection methods and processes, identifies process-improvement opportunities, and collaborates with teams to implement changes. This role drives both departmental and business objectives and typically has team-lead responsibilities.

Responsibilities

• Consistently apply Quality System standards to assigned areas.
• Develop solutions for routine activities of moderate scope and complexity.
• Follow and update applicable company/unit procedures and policies.
• Proactively manage group and personal metrics to ensure goals are tracked and met.
• Work within and across functions for assigned Quality systems.
• Resolve moderate-to-complex issues and make routine recommendations with minimal instruction.
• Provide technical guidance and training to others; lead team activities.
• Propose and implement process improvements; ensure quality execution of processes or analyses.
• Exercise sound judgment within defined practices to obtain solutions, including facilitating discussions to resolve open issues.
• Ensure timely product release and perform follow-up to prevent conflicts or delays to business goals.
• Monitor and plan daily workload for efficiency and productivity.
• Guide Manufacturing associates to ensure adherence to Quality System Procedures.
• Communicate standards and process-compliance expectations to functional-area members; escalate compliance questions/issues to management.
• Collaborate effectively with functional groups to promote a teamwork environment.
• Proactively communicate resource needs to managers.
• Initiate Nonconforming Material reports and/or Planned Deviations as needed.
• Participate in and contribute to continuous-improvement initiatives; collaborate with other departments on corrective-action plans.
• Prepare and distribute Quality Metrics related to final-inspection results.
• Act objectively in solving problems; keep manager informed of changes/issues affecting Finished Product release or quality issues from the manufacturing floor.
• Work cross-functionally to expedite urgent batches to Finished Goods Inventory (FGI).
• Review and write procedures and SOPs; initiate Engineering Change Requests (ECRs) as needed.
• Assist in troubleshooting inspection process-oriented problems.
• Assist in developing and evaluating new processes and procedures; analyze existing processes to suggest improvements.
• Follow BD Biosciences Environmental, Health, and Safety (EH&S) policies and procedures; maintain safety in the work area and participate in EH&S programs.
• Support internal customers: Operations, R&D, Production Planning, Quality Engineers, and Logistics.
• Perform other related duties and assignments as required.

Requirements

• High school diploma (minimum).
• Daily working knowledge of SAP and computer skills (Microsoft Word, Excel, email).
• Experience in pharmaceutical, biotech, medical device, regulatory, or QA preferred.
• Basic application of Quality systems principles (e.g., Document Control, Complaint Management).
• Basic knowledge of ISO 9001, ISO 13485, and other applicable regulatory bodies.
• Attention to detail, ISO 13485/9001 experience, and flexibility with changing routines (must be evident on resume).

Skills

• Self-driven and detail-oriented; able to work independently with minimal supervision.
• Strong time-management skills; ability to handle multiple tasks and meet deadlines.
• Effective organization, planning, and prioritization skills.
• Analytical and problem-solving skills.
• Strong written and oral communication skills.
• Effective interpersonal skills.
• Ability to follow established policies and procedures.

Physical Demands

• Must be able to lift 35 pounds.
• Must be able to work in various temperature environments (ambient, 4°C, -20°C, -80°C).