Quality Operations Leader: CAPA, NPI & Compliance

Philips

Reedsville (PA)

On-site

USD 120,000 - 190,000

Full time

14 days+

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Benefits offered by this job

Paid time off (PTO)

401(k) with company match

Health savings account (HSA)

Education reimbursement

Job summary

Philips is seeking a Quality Operations Manager for its Reedsville Ultrasound Transducer manufacturing site. You will lead the quality team, oversee quality operations, drive critical quality and continuous improvement initiatives, and ensure site compliance with FDA/regulatory standards.

You will manage CAPA, NCs, QNs, PFMEA impact, design transfers, product validations, and supplier quality. Strong leadership, data-driven decision making, and extensive experience in ISO 13485, 21 CFR are

Qualifications

7+ years in FDA-regulated medical device manufacturing focused on Operations/Process Quality.
Experience managing CAPA, NCs/QNs, and internal/external audits; skilled in process validation.
Knowledge of ISO 13485/14971, 21 CFR 803/806/820; GMP and GDP familiarity.

Responsibilities

Lead quality team and CAPA process; investigate nonconformances and implement corrective actions.
Oversee PFMEA impact assessments and changes; assist in design transfer activities.
Validate product transfers and New Product Introductions; ensure testing robustness and validation readiness.
Drive supplier quality improvements with cross-functional teams (R&D, manufacturing, regulatory).
Maintain and improve the Quality Management System and risk management; ensure regulatory compliance.