Quality Assurance Specialist – Medical Devices | ISO/CAPA

Prescott's, Inc; Monument (CO); Vor Ort; USD 65.000 - 70.000; Vollzeit

Benefits dieser Stelle

Paid time off

Healthcare insurance

Disability insurance

401K with company match

Professional development

Zusammenfassung

Prescott’s Med is seeking a Quality Assurance Specialist onsite at Monument, CO to uphold ISO 13485, FDA QSR (21 CFR Part 820) compliance, and robust documentation. You’ll lead nonconformance, CAPA, calibration monitoring, and audit support across Operations, Quality, and Supply Chain, while monitoring quality metrics and driving process improvements.

The role requires 2–3+ years in medical devices or regulated manufacturing, strong attention to detail, and clear cross‑functional communication.

Qualifikationen

• High school diploma or GED required; Associate's or Bachelor's degree in a related field preferred.
• 2–3+ years of experience in quality assurance, quality control, or inspection, ideally within medical devices, electronics, or a regulated manufacturing environment.
• Working knowledge of quality management systems (QMS) and inspection documentation practices.
• Ability to read and interpret technical specifications, schematics, and work instructions.
• Strong attention to detail and accurate record-keeping skills.
• Effective written and verbal communication skills for documenting findings and collaborating across teams.
• Must be able to travel 10%-15% (at least once per quarter)

Aufgaben

• Inspection & Testing: Conduct calibration monitoring on calibrated equipment.
• Quality Systems & Compliance: Maintain and support the QMS in accordance with ISO 13485, FDA QSR, and other regulatory requirements.
• Documentation: Create, revise, and maintain quality records and work instructions.
• Audits: Support internal and external audits by preparing documentation and evidence of compliance.
• Non-Conformance & CAPA: Initiate NCRs and coordinate root cause analysis; track CAPA actions.
• Reporting & Continuous Improvement: Track quality metrics and suggest process improvements; participate in cross-functional meetings.

Jobbeschreibung

Prescott’s Med is seeking a Quality Assurance Specialist onsite at Monument, CO to uphold ISO 13485, FDA QSR (21 CFR Part 820) compliance, and robust documentation. You’ll lead nonconformance, CAPA, calibration monitoring, and audit support across Operations, Quality, and Supply Chain, while monitoring quality metrics and driving process improvements.

The role requires 2–3+ years in medical devices or regulated manufacturing, strong attention to detail, and clear cross‑functional communication.