Principal Engineer

Take personal ownership and processing of designated high-complexity, high-visibility CAPAs while driving overall CAPA process acceleration across the site portfolio.

Provide guidance, coaching, and day-to-day technical direction to additional CAPA personnel - including the contract Sr. Quality Engineers - balancing workload and reviewing investigations, action plans, and effectiveness checks prior to routing.

Responsibilities:

• Support the CAPA Chair: prepare CAPA Review Board materials, pre-screen records for board readiness, present portfolio status and aging, and follow through on board decisions and commitments.
• Support Quality System updates and modifications, leading or approving revisions to CAPA procedures, templates, and training content, and performing gap analysis against ISO 13485, 21 CFR 820/QMSR, and MDSAP expectations.
• Ensure documentation compliance across the CAPA subsystem - record integrity, traceability, and audit readiness of all closed and in-flight records.
• Apply risk-based decision-making to determine the impact of systemic nonconformities on the QMS, product, and process, and to set the appropriate scope and depth of corrective action.
• Connect CAPA outcomes to the broader quality system - complaints, NCs, internal/external audit findings, risk management, and Management Review - to identify and close systemic gaps.
• Preferred: Act as SME during FDA inspections, Notified Body, and customer audits: defend CAPA records, draft and negotiate audit responses, and manage follow-up commitments to closure.

Education/Experience:

8-10 years experience required.

BENEFITS

• Medical
• Dental
• Vision
• 401(k)

EEOC Compliance:

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

DISCLAIMER

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.