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.

Pay:

$200,000.00 - $235,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off Parental leave Referral program Vision insurance

Education:

Bachelor's (Preferred)

Experience:

Engineering, Science, Quality :

5 years (Required)

ISO 13485

5 years (Required)

CAPA:

5 years (Required)

Problem-solving:

5 years (Required) Ability to

Commute:

Medway, MA 02053 (Preferred)

Work Location:

In person