Sustaining Quality Manager - Medical Device Manufacturing

Orion Global Talent; Connecticut; On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Work-life balance

Collaborative culture

Employee retention

Job summary

Orion Global Talent invites an experienced Sustaining Quality Manager to lead quality engineering activities for ongoing production, CAPA, nonconformance reduction, and process validation in a medical device setting.

You will collaborate with Operations, Manufacturing Engineering, Regulatory Affairs, suppliers and customers to ensure compliance with ISO 13485, FDA, and GMP, guide root-cause investigations, and drive continuous improvement. This position is based at the Vermont facility.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, Life Sciences or related field.

Responsibilities

• Lead and mentor Sustaining Quality Engineers and Quality Technicians.
• Ensure compliance with ISO 13485, FDA, GMP, QMS, and customer requirements.
• Manage quality performance for existing production programs.
• Lead CAPA, nonconformance, customer complaint, and root cause investigations.
• Apply problem-solving methodologies including 5 Why, Fishbone, and DMAIC.
• Monitor and improve yield, scrap, PPM, COPQ, process capability, and customer quality metrics.
• Lead continuous improvement initiatives to reduce defects and improve process stability.
• Support IQ/OQ/PQ process validation and revalidation.
• Review engineering changes, process modifications, risk assessments, and change controls.
• Serve as a key quality contact for customers and lead quality reviews and issue resolution.
• Support internal, customer, supplier, and regulatory audits.
• Partner with Supplier Quality and Purchasing on supplier performance and corrective actions.
• Develop and present quality KPIs and performance metrics to site leadership.
• Promote a strong culture of quality ownership and continuous improvement.

Skills

Quality engineering

Quality management

Leadership

Regulated manufacturing

CAPA

QMS

ISO 13485

FDA requirements

Root cause analysis

SPC

FMEA

MSA/Gage R&R

Process validation

DMAIC

Education

Bachelor’s degree in Engineering, Quality, Manufacturing, or Life Sciences

Tools

SPC

FMEA

MSA/Gage R&R

Process validation

DMAIC

Job description

Sustaining Quality Manager | Medical Device Manufacturing

Make an impact. Improve performance.

Our client, a consistently recognized “Best Place to Work,” is seeking an experienced Sustaining Quality Manager to lead quality performance and continuous improvement for established products and manufacturing processes.

This is an excellent opportunity for a quality leader who enjoys being close to manufacturing—solving problems, developing people, working with customers, and driving measurable improvements in a highly regulated environment.

The company offers a collaborative, employee-focused culture with exceptional retention and a strong commitment to work-life balance. Located in a beautiful rural setting, the area offers outstanding outdoor recreation while remaining close to world-class healthcare, educational institutions, and cultural opportunities.

The Opportunity

The Sustaining Quality Manager will lead quality engineering activities supporting ongoing production, customer satisfaction, CAPA, nonconformance reduction, process validation, supplier quality, and regulatory compliance.

Working closely with Operations, Manufacturing Engineering, Program Management, Regulatory Affairs, suppliers, and customers, you will ensure products and processes consistently meet quality, regulatory, and customer requirements.

Key Responsibilities

• Lead and mentor Sustaining Quality Engineers and Quality Technicians
• Ensure compliance with ISO 13485, FDA, GMP, QMS, and customer requirements
• Manage quality performance for existing production programs
• Lead CAPA, nonconformance, customer complaint, and root cause investigations
• Apply problem-solving methodologies including 5 Why, Fishbone, and DMAIC
• Monitor and improve yield, scrap, PPM, COPQ, process capability, and customer quality metrics
• Lead continuous improvement initiatives to reduce defects and improve process stability
• Support IQ/OQ/PQ process validation and revalidation
• Review engineering changes, process modifications, risk assessments, and change controls
• Serve as a key quality contact for customers and lead quality reviews and issue resolution
• Support internal, customer, supplier, and regulatory audits
• Partner with Supplier Quality and Purchasing on supplier performance and corrective actions
• Develop and present quality KPIs and performance metrics to site leadership
• Promote a strong culture of quality ownership and continuous improvement

What We're Looking For

• Bachelor’s degree in Engineering, Quality, Manufacturing, Life Sciences, or related discipline
• 7+ years of Quality Engineering or Quality Management experience in regulated manufacturing
• 3+ years of leadership experience
• Strong knowledge of ISO 13485, FDA requirements, CAPA, QMS, SPC, FMEA, MSA/Gage R&R, and process validation
• Experience with medical devices, injection molding, assembly, or highly regulated manufacturingstrongly preferred
• Demonstrated success leading root cause analysis and continuous improvement initiatives
• Strong communication, organizational, and cross-functional leadership skills

Preferred Certifications

ASQ Certified Quality Manager (CMQ/OE), ASQ Certified Quality Engineer (CQE), and/or Lean Six Sigma Green Belt or Black Belt.

Why Consider This Opportunity?

Beyond the technical challenge, this is an opportunity to join an organization known for its strong culture, high employee retention, collaborative leadership, and commitment to work‑life balance.

If you are an experienced Quality Manager or Senior Quality Engineer ready to take on a broader leadership role in a regulated manufacturing environment, we would like to hear from you.

This position is at our client's Vermont manufacturing facility.