Sustaining Quality Manager

The Sustaining Quality Manager is responsible for maintaining and continuously improving the quality performance of existing products and manufacturing processes.

Nolato is a global leader in precision injection molding and contract manufacturing for the world’s most successful healthcare, automotive, and industrial OEMs.Join an organization that is respected throughout the industry for our advanced technology, quality, and innovation – all while enjoying the benefits of stable ownership, a collaborative culture, professional development, continuing education, global opportunities, and an exceptional benefits package.

The Sustaining Quality Manager is responsible for maintaining and continuously improving the quality performance of existing products and manufacturing processes. This role leads quality engineering activities related to production, customer satisfaction, nonconformance reduction, CAPA effectiveness, process validation maintenance, supplier quality support, and regulatory compliance.

The Sustaining Quality Manager works closely with Operations, Manufacturing Engineering, Program Management, Regulatory Affairs, and customers to ensure products consistently meet quality, regulatory, and customer requirements.

• Ensure compliance with applicable quality standards, including ISO 13485, FDA, GMP, and customer-specific requirements.
• Support internal, customer, and regulatory audits.
• Maintain quality system procedures, work instructions, and quality records.
• Lead Management Review quality metrics and reporting activities.

• Manage quality performance of existing production programs.
• Monitor process capability, yield, scrap, and customer quality metrics.
• Drive continuous improvement initiatives to reduce defects and improve process stability.
• Analyze trends and identify opportunities for quality improvement.

• Lead investigations into customer complaints, internal nonconformances, and audit findings.
• Ensure effective root cause analysis using methodologies such as 5 Why, Fishbone, and DMAIC.
• Manage Corrective and Preventive Action (CAPA) activities through closure.
• Verify effectiveness of corrective actions.

• Direct and mentor Sustaining Quality Engineers and Quality Technicians.
• Establish departmental goals, objectives, and performance expectations.
• Allocate resources to support production, validation, and customer requirements.
• Promote a culture of quality ownership throughout the organization.

• Serve as primary quality contact for existing customer programs.
• Lead customer quality reviews and issue resolution activities.
• Support customer audits and corrective action responses.
• Monitor customer scorecards and drive improvement plans where needed.

• Support revalidation activities for manufacturing processes and equipment.
• Review and approve engineering changes and process modifications.
• Participate in risk assessments and change control activities.
• Ensure quality requirements are maintained throughout process changes.

• Partner with Supplier Quality and Purchasing teams to address supplier-related quality issues.
• Evaluate supplier performance metrics and improvement opportunities.

• Develop and report key performance indicators (KPIs) including:
  • Customer complaints
  • Internal PPM
  • Scrap rates
  • Cost of Poor Quality (COPQ)
  • CAPA closure performance
  • Audit findings
  • Yield and process capability metrics
• Present quality performance to site leadership.

• Bachelor’s degree in engineering,Quality, Manufacturing, Life Sciences, or related field required.
• Master's degree preferred.

• 7+ years of Quality Engineering or Quality Management experience in a regulated manufacturing environment.
• 3+ years of leadership experience.
• Experience with medical devices, injection molding, assembly, or highly regulated manufacturing preferred.
• Strong understanding of statistical methods and quality tools.

• CAPA Management
• Statistical Process Control (SPC)
• Process Validation (IQ/OQ/PQ)
• MSA and Gage R&R
• Lean Manufacturing and Continuous Improvement
• Quality Management Systems (QMS)
• Customer and Regulatory Audits

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

• Proficient in Microsoft Office Suite & Windows operating systems.
• Excellent communication, time management and organizational
• Ability to manage multiple priorities and accounts.
• Must be able to function well in a team-oriented
• Flexibility to work additional hours when needed.
• Professional demeanor and appearance.
• Must have a continuous improvement mindset

Royalton, VT, United States, United States