Senior QMS Manager - Regulated Manufacturing

Kopin Corporation; Westborough, Northern (MA, KY); Hybrid; USD 135,000 - 160,000; Full time

Job summary

Kopin Corporation in Westborough, MA seeks a Quality Manager to establish and sustain a scalable QMS across multiple manufacturing sites, aligned with AS9100, ISO 13485, and ISO 9001. You will lead cross-functional teams including manufacturing, engineering, NPI, and supply chain to drive quality performance and regulatory compliance.

Responsibilities include leading internal and external audits, CAPA systems, supplier quality, and data-driven improvement using SPC/DOE/Minitab.

Qualifications

• Bachelor’s degree (B.S.) or higher in Engineering or a relevant discipline.
• 8+ years of quality management 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.

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.
• 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.
• 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.
• Partner with engineering, production, supply chain to embed quality 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.

Skills

Audits

CAPA leadership

Risk management

Cross-functional leadership

Communication skills

Self-motivation

Education

Bachelor’s degree in Engineering

Tools

SPC

DOE

Minitab

MS Office

Job description

Kopin Corporation in Westborough, MA seeks a Quality Manager to establish and sustain a scalable QMS across multiple manufacturing sites, aligned with AS9100, ISO 13485, and ISO 9001. You will lead cross-functional teams including manufacturing, engineering, NPI, and supply chain to drive quality performance and regulatory compliance.

Responsibilities include leading internal and external audits, CAPA systems, supplier quality, and data-driven improvement using SPC/DOE/Minitab.