Senior Quality Systems Engineer

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Located in Medway, MA

Salary: $93K - 116K/year

We are seeking an Experienced Senior Quality Systems Engineer to join our client's team as a key member of the Quality Systems department.

Work schedule: (M-F) 8am - 5pm

Pay rate range: $93,000 -$116,000/year

Job Requirements

• Bachelor’s degree (or equivalent) in Engineering, Science, Quality or a related discipline.
• A minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience.
• Additional qualification in Quality Assurance or a related discipline is preferred.
• ISO 13485 Auditor training and/or Lead Auditor qualification is preferred.

General Responsibilities:

• Prioritise and manage workload to ensure critical Quality System activities are delivered on time
• Escalate compliance risks and resource constraints appropriately
• Support broader Quality or site activities where required, provided core Quality Systems responsibilities are not impacted

Essential skills and experience

• Strong working knowledge of ISO13485 and applicable regulatory requirements.
• Experience in CAPA, internal auditing, customer complaints and audit support, including leading audits and supporting external inspections.
• Proven ability to lead investigations and drive timely resolution of quality issues, including root cause analysis and follow-up actions.
• Experience working with electronic Quality Management Systems (eQMS), including data management, tracking and reporting of Quality Systems activities.
• Experience working cross-functionally and influencing stakeholders across Quality and Operations.
• Strong problem-solving, organizational and communication skills, with the ability to work independently, manage priorities and escalate risks appropriately.

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