Senior Quality Manager

Lead Enterprise Quality Strategy

Lead the development, implementation, and continuous improvement of the Quality Management System (QMS). Establish quality goals, policies, and procedures aligned with site and enterprise objectives. Partner with cross-functional leaders to promote a culture of quality and compliance throughout the organization. Serve as the quality lead on strategic projects, providing guidance on timelines, risk mitigation, and quality requirements. Manage internal audit programs and oversee corrective actions resulting from customer, regulatory, and certification audits. Present quality performance metrics, compliance findings, and improvement recommendations to executive leadership. Oversee CAPA, complaint handling, quality investigations, and other critical quality system processes. Facilitate Management Review activities and support continuous improvement initiatives across operations. Lead implementation of quality improvement methodologies including SPC, FMEA, root cause analysis, and Six Sigma tools. Manage inspection, calibration, metrology, and measurement system programs to ensure accuracy and compliance. Act as the primary quality contact during customer audits, external assessments, and regulatory inspections. Analyze quality trends and operational metrics to identify improvement opportunities and reduce risk. Lead risk management activities for products and manufacturing processes. Oversee customer complaint investigations and ensure timely resolution through effective CAPA execution. Support validation, FAI reporting, capability studies, and measurement system analysis activities. Recruit, mentor, and develop high-performing quality professionals.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Bachelor's degree in Engineering, Quality, Applied Science, Business, or a related technical discipline. Experience in a CMO (Contract Manufacturing Organization). Experience with Thermoplastic Injection Molding. 5+ years of quality management experience or 10+ years of progressive quality assurance/quality control leadership experience. Manufacturing industry experience required; medical device experience strongly preferred. Strong knowledge of FDA regulations, ISO 13485, ISO 14971, EU MDR, and related quality standards. Experience managing CAPA systems, internal audits, complaint handling, risk management, and validation activities. Expertise in APQP, control plans, metrology, MSA, FAI, capability studies, and statistical quality methodologies. Proven success leading continuous improvement and structured problem-solving initiatives. Strong leadership, communication, and stakeholder management skills. Ability to influence cross-functional teams and executive-level decision makers. ASQ certifications such as CMQ/OE, CQE, or CQA are highly preferred.

Competitive salary ranging from $130,000 to $165,000 annually. Opportunity to shape and elevate the organization's quality strategy. High-visibility leadership role with direct interaction with executive leadership. Significant influence on operational performance and business outcomes. Lead meaningful continuous improvement and compliance initiatives. Join a company that values innovation, professional growth, and employee engagement

Sector: Engineering & Manufacturing

Sub Sector: Quality, Technical

Industry: Healthcare / Pharmaceutical

Where: Leominster

Contract Type: Permanent

Job Reference: JN-092026-7115946