Quality Manager

Quality Manager Dyme Medical Marlborough, MA Job Details Full-time $110,000 - $130,000 a year 17 hours ago Benefits Relocation assistance Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Quality control corrective actions Record keeping Document review (document control) 7 years Electro-mechanical components Laboratory equipment maintenance Sterilization ISO standards Engineering Supplier quality engineering practices Regulatory compliance Corrective and preventive actions (CAPA) Quality management Complaint handling Laboratory equipment calibration Material testing Product development projects Bachelor's degree in engineering Bachelor's degree Quality control documentation Scientific protocols Packaging Usability Quality inspection Design controls FMEA Continuous quality improvement (CQI) Laboratory management Manufacturing Senior level Instrument maintenance Cross-functional collaboration Document management systems Risk assessment implementation Communication skills

ISO 13485

Regulatory compliance management Cross-functional communication FDA regulations Engineering validation Full Job Description About the Role We are seeking a Quality Manager to lead and strengthen the quality function for the development a next-generation insulin pump system. This role will partner closely with Engineering, Manufacturing, Regulatory, and external laboratories and suppliers to build a practical, inspection-ready quality system that supports rapid product development. The Quality Manager will own critical quality processes across design and development, supplier quality, incoming inspection, device history and lot records, nonconforming material, CAPA, traceability, and post-market quality activities. This person must be comfortable operating in a hands-on, high-accountability environment and must understand the quality and regulatory expectations that apply to software-enabled medical devices and combination electromechanical systems. Key Responsibilities

• Lead implementation, maintenance, and continuous improvement of the quality management system for medical device development and manufacturing, aligned to FDA requirements.
• Provide quality leadership for design and development activities, including design reviews, risk assessment, traceability, change control, verification/validation readiness, and maintenance of the Design History File (DHF), Device Master Record (DMR).
• Scales the quality system as the company grows from startup to production transfer.
• Own incoming inspection, supplier quality controls, certificates of conformance/analysis, lot and serial control, and nonconforming material review.
• Support pilot manufacturing operations.
• Writes protocols with strong statistical rationale.
• Manage or coordinate external test activities, including biocompatibility, biological evaluation, extractables/leachables, sterilization, environmental or materials testing, and on-site laboratory management as needed.
• Work cross-functionally in a startup-style environment to build scalable procedures, practical documentation practices, and a culture of quality that enables execution.
• Owns and maintains document control system.
• Owns and maintains equipment calibration and maintenance. Regulatory and Standards Knowledge The ideal candidate should have working knowledge of, and experience applying, the regulations and standards most relevant to insulin pump and connected medical device development, including:
• FDA Quality Management System Regulation (21 CFR Part 820), including the FDA's harmonized QMSR framework incorporating

ISO 13485

2016 requirements.

• FDA device lifecycle expectations related to design controls, risk management, supplier controls, complaint handling, and post-market quality activities.

IEC 62304

for medical device software lifecycle processes, especially where software is embedded in or supports a regulated device.

ISO 14971

for medical device risk management across design, manufacturing, and post-market phases.

IEC 62366-1

/ human factors and usability engineering expectations applicable to insulin delivery devices and user-interface risk reduction.

• Biocompatibility expectations and use of ISO 10993-based evaluation strategies for patient-contacting materials, as applicable. Required Qualifications
• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field; advanced degree or relevant quality certification is a plus.
• 7-10 years of progressive experience in Quality Engineering or Quality Management within the medical device industry, with direct experience supporting regulated product development.
• Demonstrated experience supporting Class II medical devices, preferably with electromechanical, disposable, software-enabled, or drug-delivery products.
• Strong understanding of design control deliverables, DMR/DHF structure, change control, supplier quality, incoming inspection, NCR/CAPA, and manufacturing quality systems.
• Experience working with external test laboratories, contract manufacturers, component suppliers, and cross-functional engineering teams.
• Familiarity with sterilization, primary and secondary packaging validation
• Hands-on experience building practical quality processes in a fast-moving or resource-constrained environment; able to operate strategically and tactically.
• Strong written and verbal communication skills, with the ability to coach teams, challenge constructively, and drive closure on quality issues. Success Profile
• Builds quality systems that are rigorous, right-sized, and usable by the team.
• Understands how to balance development speed with compliance, and product reliability.
• Brings ownership, judgment, and follow-through to company growth and quality objectives.

Pay:

$110,000.00 - $130,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Relocation assistance Vision insurance

Work Location:

In person