Quality Manager

POSITION: Quality Manager
LOCATION: Westborough, MA
REPORTING TO: VP of Operations

GENERAL FUNCTION:

The Quality Manager is responsible for establishing, developing, implementing, and maintaining a robust, compliant, and scalable Quality Management System (QMS) across multiple manufacturing sites. This role ensures alignment with aerospace, defense, and medical device industry standards—including AS9100, ISO 13485, and ISO 9001—and leads enterprise-wide initiatives focused on product quality, regulatory compliance, operational excellence, continuous improvement, and customer satisfaction. The Quality Manager is a cross-functional leader partnering closely with Manufacturing Operations, Engineering, New Product Introduction (NPI), Supply Chain, and Program Management to uphold quality performance, drive standardization, reduce variation, and strengthen quality culture across all facilities.

JOB DUTIES AND RESPONSIBILITIES:

• Develop, deploy, and maintain an integrated QMS across all sites to ensure consistency, compliance, and readiness for internal, customer, and regulatory audits.
• Lead cross-site harmonization initiatives, standardizing procedures, documentation, inspection methodologies, and quality controls.
• Ensure all facilities meet and sustain compliance with AS9100, ISO 13485, ISO 9001, applicable regulatory expectations, and customer-specific requirements.

Quality Assurance & Control

• Direct quality personnel involved in inspection, auditing, and quality control activities (IQC, OQC, quality engineering).
• Develop and oversee quality control plans, inspection guidelines, and process controls for new and existing products.
• Lead internal audits and manage external audits; ensure timely mitigation of findings and preventive action execution.

Corrective Action, Risk, and Compliance Management

• Lead root cause investigations using rigorous problem-solving methods (8D, fishbone, DMAIC, 5-Why).
• Own the corrective and preventive action (CAPA) system, ensuring timely resolution, systemic prevention, and robust documentation.
• Oversee measurement systems, gage R&R, calibration compliance, and metrology requirements.
• Develop supplier quality standards and qualification criteria aligned with industry and regulatory requirements.
• Lead supplier audits, performance reviews, and improvement programs.
• Oversee incoming material inspection, traceability, and material disposition workflows (MRB)
• Champion continuous improvement initiatives to improve yield, reduce scrap, enhance process capability, and optimize cost of quality.
• Utilize statistical tools (SPC, DOE, Minitab) to improve decision-making, predict trends, and drive process improvements.
• Publish quality metrics across sites, including product performance, supplier KPIs, CAPA effectiveness, and compliance status.

Cross-Functional Leadership

• Partner with engineering, production, supply chain teams to ensure quality considerations are embedded early in design and throughout the product lifecycle.
• Oversee training programs to develop quality competencies across the organization.
• Represent Quality in customer reviews, regulatory inspections, and program meetings.

MINIMUM

JOB REQUIREMENTS:

• Bachelor’s degree (B.S.) or higher in Engineering or a relevant discipline.
• 8+ years of quality management and/or engineering work experience in a regulated manufacturing environment.
• Demonstrated experience developing, leading, or maintaining QMS systems compliant with AS9100, ISO 13485, or ISO 9001.
• Strong experience with audits, CAPA leadership, supplier quality, and risk management methodologies.
• Proficiency with statistical tools (SPC, DOE, Minitab) and data-driven quality improvement.
• Ability to interpret engineering drawings, mechanical/electrical schematics, and technical documentation.
• Proven leadership and communication skills; ability to engage and influence cross-site teams.
• Ability to operate independently with urgency, resourcefulness, and adaptability.
• Demonstrated excellence in interpersonal and communication skills as evidenced by successful interaction with various levels of management, state and federal regulators, stakeholders and suppliers.
• Advanced ability to work with minimal direction to accomplish general programmatic objectives.
• Self-motivated with high sense of urgency, resourcefulness and adaptability.
• Basic software skills (Word, Excel, PowerPoint, Outlook, SPC and shop floor management etc.).

PREFERRED

JOB REQUIREMENTS:

• ASQ certifications (CQE, CQA, CMQ/OE, SSGB/SSBB).
• Experience in both hardware and…