The Sustaining Quality Manager is responsible for maintaining and continuously improving the quality performance of existing products and manufacturing processes.
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.
Essential Duties and Responsibilities Quality Systems & Compliance - 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.
Sustaining Product Quality - 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.
CAPA & Nonconformance Management - 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.
Quality Engineering Leadership - 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.
Customer Quality Support - 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.
Process Validation & Change Management - 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.
Supplier Quality Support - Partner with Supplier Quality and Purchasing teams to address supplier-related quality issues.
- Support supplier corrective action activities.
- Evaluate supplier performance metrics and improvement opportunities.
Metrics & Reporting - 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.
Qualifications: Education - Bachelor's degree in engineering, Quality, Manufacturing, Life Sciences, or related field required.
- Master's degree preferred.
Experience - 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.
Technical Skills - Root Cause Analysis
- CAPA Management
- Statistical Process Control (SPC)
- Risk Management (FMEA)
- Process Validation (IQ/OQ/PQ)
- MSA and Gage R&R
- Lean Manufacturing and Continuous Improvement
- Quality Management Systems (QMS)
- Customer and Regulatory Audits
Certifications (Preferred) - ASQ Certified Quality Manager (CMQ/OE)
- ASQ Certified Quality Engineer (CQE)
- Lean Six Sigma Green Belt or Black Belt
In Addition - 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.
- Some travel may be
- Must have a continuous improvement mindset
