Post-Market Quality Inspector

Quality Inspector

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

The Quality Inspector plays a critical role in maintaining the safety, reliability, and compliance of Applied Medical's medical devices following clinical use. This post-market quality inspector position ensures that returned products meet Applied Medical's stringent quality standards while supporting patient safety and continuous product improvement. Working within an ISO 13485 and FDA-regulated environment, the Quality Inspector performs detailed inspections, documentation, and collaboration with cross-functional teams to support ongoing product integrity and regulatory compliance.

Key Responsibilities

• Inspect and assess returned medical devices to verify condition, cleanliness, and compliance with safety and decontamination standards.
• Use calibrated measuring tools to confirm product integrity against specifications. Document findings in Applied Medical's enterprise resource planning (ERP) and electronic quality management system (eQMS) platforms with accuracy and traceability.
• Collaborate cross-functionally with the Servicing, Regulatory Affairs, and Customer Relations teams to resolve documentation discrepancies and product concerns.
• Maintain compliance with applicable regulatory standards, including 21 CFR Part 820, ISO 9001, and ISO 13485.
• Support continuous improvement initiatives by contributing feedback.
• Adhere to safety protocols when handling decontaminated or potentially biohazardous materials in accordance with bloodborne pathogen procedures.

Success in This Role Looks Like

• Conducts accurate and efficient inspections that uphold Applied Medical's quality and safety standards.
• Contributes to clear, compliant, and timely documentation that supports post-market surveillance and regulatory reporting.
• Demonstrates precision, consistency, and accountability in all inspection and verification activities.
• Builds strong working relationships with cross-functional partners to resolve quality issues and improve processes.
• Supports Applied Medical's mission of delivering reliable, high-quality devices that advance patient care and clinical outcomes.

Position Requirements

• High school diploma or equivalent education.
• Minimum of two years of experience in quality assurance or inspection within a regulated manufacturing environment (e.g., medical device, pharmaceutical, or aerospace).
• Working knowledge of ISO and FDA regulatory frameworks, including 21 CFR Part 820.
• Strong analytical skills with meticulous attention to detail.
• Proficiency in ERP and eQMS systems for data entry and documentation (e.g., SAP).
• Clear written and verbal communication skills in English.
• Ability to lift between fifteen and twenty-five pounds on an occasional to regular basis.
• Organizational discipline and the ability to manage time effectively in a fast-paced environment.

Preferred

• Experience working in a medical device manufacturing or clinical servicing environment.
• Familiarity with bloodborne pathogen protocols, product decontamination, and sterilization processes.
• Exposure to continuous improvement methodologies such as Lean or Six Sigma.
• Understanding of ISO 13485 quality systems and regulatory documentation practices.

Benefits

• Competitive compensation range: $18 - 23 / hour (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply.

Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

Equal Opportunity Employer

Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.