Director, Quality

Resonetics; Bethel (CT); On-site; USD 144,000 - 222,000; Full time

Job summary

Resonetics in Bethel, CT is seeking a Quality Director to lead operational quality and QMS compliance in a fast-paced medical device contract manufacturing facility. You will own quality performance, drive SPC and process validation, and partner with Operations to embed quality on the shop floor.

The role requires at least 7 years in medical device quality management, ISO 13485 and FDA inspection experience, and a BS in engineering or management.

Qualifications

• Minimum 7 years in Medical Device Quality Management.
• Lean Six Sigma Green Belt or Black Belt preferred.
• Experience hosting FDA inspections and ISO audits.
• Strong communication skills, both written and verbal.
• BS degree in engineering or management.

Responsibilities

• Own and lead manufacturing quality performance across the site.
• Embed quality into daily production activities with Operations.
• Oversee SPC, process capability and data-driven improvements.
• Manage quality metrics, CAPA, and risk management.
• Lead NPI quality, process validation and validation strategies.
• Drive supplier quality program and customer interface.
• Build and mentor a high‑performing quality team.

Skills

Communication skills

FDA inspections experience

ISO audits experience

Regulated environment experience

Education

BS in engineering or management

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

This Quality Director plays a pivotal role in leading and strengthening operational quality and quality compliance within a large-scale contract manufacturing facility. Responsible for both Product Quality and Quality Management System (QMS) compliance, this leader ensures quality operations within the manufacturing environment consistently meet customer, regulatory, and business expectations.

This individual combines strategic vision with hands‑on operational quality leadership, ensuring Resonetics delivers world‑class quality in a fast‑paced, highly regulated medical device manufacturing environment. The role demands proven experience within manufacturing operations, deep expertise in ISO 13485 and 21 CFR Part 820, mastery of advanced quality assurance techniques, and the ability to align and elevate quality performance across multiple value streams.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast‑paced environment, we’d love to hear from you.

Operational Quality Leadership

• Own and lead all aspects of manufacturing quality performance, ensuring operational processes deliver consistent, compliant, and high‑yield outcomes.
• Partner closely with Operations leadership to embed quality into daily production activities and drive problem‑solving directly on the manufacturing floor.
• Implement and oversee statistical process control (SPC), process capability, and other data‑driven tools to ensure process stability and continuous improvement.
• Monitor and manage critical quality metrics, taking immediate action to address gaps and prevent recurrence of issues.
• Oversee validation strategies (IQ/OQ/PQ) for manufacturing processes and equipment, ensuring robustness and compliance.
• Provide quality leadership in New Product Introduction (NPI), ensuring robust process validation, risk management, and seamless transition from development into full‑scale manufacturing.

Quality Systems & Compliance

• Ensure the ISO‑certified QMS is operationally effective within manufacturing sites and continuously improved to support business growth.
• Maintain full compliance with ISO 13485, 21 CFR Part 820, and other relevant standards through proactive system management and audit readiness.

Continuous Improvement & Problem Solving

• Lead root cause investigations and corrective actions for complex production challenges.
• Drive Lean and Six Sigma initiatives that enhance manufacturing efficiency while strengthening compliance and product quality.
• Share best practices across sites to ensure standardization and scalability of quality improvements.

Customer & Supplier Interface

• Serve as the primary quality leader for high‑visibility customers, ensuring confidence in Resonetics’ ability to deliver consistently high‑quality products.
• Lead the supplier quality program, ensuring raw materials and outsourced processes meet stringent requirements to support operational excellence.

Team Leadership & Development

• Build and mentor a strong quality team embedded within the manufacturing organization.
• Provide training in advanced quality tools (Gage R&R, SPC, pFMEA, Risk Analysis, Validation, Root Cause Analysis, CAPA) to elevate operational capability.
• Foster a culture of quality culture and ownership on the production floor, engaging all levels of the workforce.

Required Qualifications

• Minimum 7 years’ experience in a Medical Device Quality Management role.
• Lean and/or Six Sigma Green Belt or Black Belt
• Demonstrated background in an ISO 13485 and 21 CFR 820 quality management system.
• Strong communication skills (verbal and writing)
• BS degree in a management or engineering discipline
• Experience hosting FDA inspections and ISO audits

Preferred Qualifications

• Prior experience in a technical, regulated environment.
• Experience with finished medical device assembly and oversight of sterilization
• Experience with Quality Management Software (eQMS) and ERP systems
• Certified Quality Auditor

Physical Demands

• Light office work, approximately 25%+ travel

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $144,000.00 - $222,000.00.

For temp, temp-to-hire, and regular full‑time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.