Philips

4 days ago

Quality Operations Manager-Ultrasound

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Manage quality operations for a Reedsville ultrasound transducer manufacturing site, including rigorous CAPA execution, nonconformance/quality notification oversight, and corrective action effectiveness monitoring. Plan and support PFMEA impact assessments for design changes, lead validation robustness for product transfers, and ensure NPI/product transfer activities meet quality norms. Drive supplier quality improvements, lead cross-functional quality engineering and assurance tasks, and manage team performance while ensuring QMS, risk management, and regulatory compliance.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Business Operations

Seniority: Manager level

Key Responsibilities

•Manage the CAPA process, including investigating nonconformances, determining root causes, implementing corrective/preventive actions, monitoring effectiveness, and overseeing NC and QN management.
•Assess PFMEA impact for design changes and support manufacturing process development and design transfer activities.
•Oversee validation robustness for product transfer validations in the factory, report project status for new products/transfers, and ensure validation activities and employee capabilities support process controls and NPI completion.
•Drive supplier quality improvement initiatives and resolve quality non-conformities with internal suppliers; lead process validation as the local factory-level QMS process owner to ensure quality and regulatory adherence.
•Lead and manage the quality team, including talent management, performance and compensation management, career development, and maintaining manufacturing quality systems with risk management and process improvement.

Travel: Low travel

Pay and Benefits

Salary: USD 120,000 - 190,000 annually

Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

•Minimum 7+ years’ experience in FDA-regulated medical device manufacturing environments, focused on operations/process quality (IQ/OQ/PQ), nonconformance events, CAPA, audits, and process validation/continuous improvement.
•Proven experience managing quality teams, including budgeting, workforce planning, performance management, engagement/retention, succession planning, coaching, and training.
•Strong understanding of medical device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/EU MDR, GMP, and GDP.
•Proven experience using quality KPIs and data analysis to assess performance and identify process and continuous improvement opportunities.
•Bachelor’s degree in Quality, Engineering, or a related scientific discipline (required); ASQ certifications are desired.

Experience:7+ yearsMedical devicesFDA-regulated manufacturing

Education:Bachelor's in Quality, Engineering, or a related scientific discipline

Skills:LeadershipCommunicationInfluenceRelationship buildingCross-functional collaboration

Certifications:ASQ

Tech Stack:CAPANon-ConformancesQuality NotificationsPFMEAIQ/OQ/PQProcess validationContinuous improvementNPIQMSISO 13485ISO 1497121CFR 80321CFR 80621CFR 820MDDEU MDRGMPGDP

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips

Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn

Loading job details...

Preparing the role view and application actions.

Philips

4 days ago

Quality Operations Manager-Ultrasound

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Business Operations

Seniority: Manager level

Key Responsibilities

•Manage the CAPA process, including investigating nonconformances, determining root causes, implementing corrective/preventive actions, monitoring effectiveness, and overseeing NC and QN management.
•Assess PFMEA impact for design changes and support manufacturing process development and design transfer activities.
•Oversee validation robustness for product transfer validations in the factory, report project status for new products/transfers, and ensure validation activities and employee capabilities support process controls and NPI completion.
•Drive supplier quality improvement initiatives and resolve quality non-conformities with internal suppliers; lead process validation as the local factory-level QMS process owner to ensure quality and regulatory adherence.
•Lead and manage the quality team, including talent management, performance and compensation management, career development, and maintaining manufacturing quality systems with risk management and process improvement.

Travel: Low travel

Pay and Benefits

Salary: USD 120,000 - 190,000 annually

Perks:Paid Leave401kHsaEquityLearning Budget

Key Requirements

•Minimum 7+ years’ experience in FDA-regulated medical device manufacturing environments, focused on operations/process quality (IQ/OQ/PQ), nonconformance events, CAPA, audits, and process validation/continuous improvement.
•Proven experience managing quality teams, including budgeting, workforce planning, performance management, engagement/retention, succession planning, coaching, and training.
•Strong understanding of medical device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/EU MDR, GMP, and GDP.
•Proven experience using quality KPIs and data analysis to assess performance and identify process and continuous improvement opportunities.
•Bachelor’s degree in Quality, Engineering, or a related scientific discipline (required); ASQ certifications are desired.

Experience:7+ yearsMedical devicesFDA-regulated manufacturing

Education:Bachelor's in Quality, Engineering, or a related scientific discipline

Skills:LeadershipCommunicationInfluenceRelationship buildingCross-functional collaboration

Certifications:ASQ

Tech Stack:CAPANon-ConformancesQuality NotificationsPFMEAIQ/OQ/PQProcess validationContinuous improvementNPIQMSISO 13485ISO 1497121CFR 80321CFR 80621CFR 820MDDEU MDRGMPGDP

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Philips

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn