About the role
Onsite, Bourne MA
The Sr. Quality Manager in our manufacturing environment serves as the strategic lead for product integrity and the primary custodian of the Quality Management System (QMS). This role balances high-level compliance—such as preparing for ISO 9001/17025 audits—with hands-on production oversight to minimize defects and ensure customer satisfaction.
Core Responsibilities
- QMS Leadership: Develop, implement, and maintain a QMS that complies with ISO 9001/17025 or other industry-specific standards.
- Audit Management: Plan and lead internal audits; serve as the primary liaison for third-party registrar audits and customer quality inspections.
- Continuous Improvement: Champion root cause analysis using methodologies like 5-Why, or DMAIC to address non-conformances and reduce scrap or rework.
- Compliance & Documentation: Oversee document control, ensuring all work instructions, quality manuals, and records are current and accessible.
- Team Supervision: Lead and mentor a team of quality engineers, technicians, and inspectors to ensure standards are met at every production stage.
- Supplier Quality: Evaluate and monitor vendor performance, conducting supplier audits as necessary to ensure raw material integrity.
- Performance Reporting: Track and report on key performance indicators (KPIs) such as defect rates, First Pass Yield, and cost of quality to senior management.
Required Skills & Qualifications
- Education: A Bachelor’s degree in Engineering, Quality Management, or a related technical field is required.
- Experience: 5+ years of quality experience in manufacturing, with at least 3 years in a leadership or ISO management role.
- Technical Knowledge: Deep understanding of ISO 9001:2015 requirements and experience with tools like PPAP (Production Part Approval Process), FMEA, and SPC (Statistical Process Control).
- Certifications: Professional certifications such as ASQ Certified Manager of Quality (CMQ/OE), Certified Quality Engineer (CQE), or ISO Lead Auditor are highly preferred.
- Methodologies: Proficiency in Lean Manufacturing or Six Sigma (Green or Black Belt) to drive operational excellence.
Key Performance Indicators (KPIs)
- Successful maintenance of ISO certifications with zero major non-conformances.
- Reduction in the Cost of Poor Quality (COPQ).
- Improvement in customer satisfaction scores and a decrease in customer complaints.
- Timely closure of Corrective and Preventive Actions (CAPA).
Workplace Environment: The work environment characteristics described here are representative of those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Physical Demands: The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Office employees: The employee must frequently lift and/or move up to 10 pounds. Light assembly employees, engineers and warehouse. The employee must frequently lift and or move up to 50 lbs.
Other duties as assigned.