Quality Engineer I

Entry-Level Quality Engineer supporting the Quality Management System (QMS) at a medical device manufacturing site in Billerica, MA.

Job Requirements

• Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial Engineering, or related field

• 0–5 years of experience in engineering, quality, or manufacturing (internships, co-ops, or full-time roles)

• Experience in a medical device or pharmaceutical environment

• Experience with Good Manufacturing Practices (GMP) and regulatory compliance

• Experience performing root cause analysis

• Ability to work onsite 40 hours per week in Billerica, MA

Preferred Skills

• Internship or co-op experience in a medical device, pharmaceutical, or manufacturing environment

• Knowledge of Six Sigma, Lean Manufacturing, and process improvement methodologies

• Familiarity with risk management tools such as FMEA for equipment and tooling

• Knowledge of FDA, ISO 13485, and other relevant regulatory and quality system requirements

• Experience supporting complaint investigations, CAPA activities, and internal/external audits

Job Responsibilities

• Support the site Quality Management System (QMS) for a regulated medical device manufacturing environment

• Conduct root cause analysis and support implementation of corrective and preventive actions (CAPAs) for process deviations and non-conformances

• Participate in internal and external audits and provide follow-up support for quality system actions

• Support risk management activities, including FMEA for equipment, tooling, and processes

• Assist with complaint investigations by reviewing lot history records and manufacturing process data

• Support the development and execution of manufacturing change implementation plans

• Ensure adherence to GMP, FDA, ISO 13485, and other applicable regulatory and quality system requirements

• Collect, document, and analyze quality data to identify trends and support continuous improvement initiatives

Pay Details: $30.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.