Quality Engineering Specialist

The Quality Engineering Specialist ensures products meet specifications and quality standards through inspection, testing, and accurate recordkeeping. This position supports day-to-day Quality Management System (QMS) activities such as incoming, in process, final inspection, nonconforming material control, calibration, document control, and change implementation on the production floor. The Quality Engineering Specialist provides exposure to FDA, ISO, and other regulatory requirements while working closely with Quality Engineers and cross functional teams.The Quality Engineering Specialist ensures products meet specifications and quality standards through inspection, testing, and accurate recordkeeping. This position supports day-to-day Quality Management System (QMS) activities such as incoming, in process, final inspection, nonconforming material control, calibration, document control, and change implementation on the production floor. The Quality Engineering Specialist provides exposure to FDA, ISO, and other regulatory requirements while working closely with Quality Engineers and cross functional teams.

On-site from Woodbury, MA

• Support corrective and preventive actions (CAPA) by gathering data, performing verification checks, and documenting results.
• Assist with document control tasks, including routing, controlled copy distribution, and ensuring current versions are available at points of use.
• Assist complaint investigations by coordinating sample pulls, conducting basic tests, and documenting observations.
• Participate in internal audits as an auditor in training, collecting objective evidence and supporting audit followup.

• Collaborate with Production, Engineering, Supply Chain, and Regulatory to resolve quality issues.
• Help prepare for external audits and inspections by organizing records and retrieval of QMS documentation.
• Support regulatory submission activities by locating and assembling required QMS records.
• Participate in quality improvement initiatives and cross functional projects as directed.

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Familiar with quality system concepts (e.g., audit, CAPA, nonconforming product, document control).
• Experience in ISOcertified environments (ISO 9001 or ISO 13485) or equivalent.
• Strong attention to detail, organization, and communication skills with the ability to work independently and in a team environment.

• Experience in a medical device or other regulated industry (ISO 13485 and/or FDA 21 CFR Part 820).
• Experience with electronic QMS platforms and/or ERP systems.
• ASQ certification (e.g., CQI, CQT) or Internal Auditor training.

• Comprehensive benefits package including medical, dental, and vision insurance.
• Generous Paid Time Off including paid holidays and floating holidays.
• 401(k) employer match on retirement planning.
• Hybrid working schedule for eligible positions.
• Tuition reimbursement on approved programs.
• Flexible and health spending accounts.
• Talent Development program.

Minimum Salary: $66,002

Maximum Salary: $88,359

We consider various factors in determining actual pay including your skills, qualifications, and experience. In addition to salary, this position is eligible for incentive awards based on individual and business performance as well as competitive benefits.