Quality Engineer I

880 Technology Park Drive Billerica, MA 01821 US

Posted: 11/13/2025 2025-11-13 2025-12-14 Employment Type: Contract Job Category: Engineering Job Number: 623873 Is job remote?: No Country: United States

Job Description

• Education Required:
• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.

Years’ Experience Required: 0-5 yrs A Day in the Life

Begin an impactful career at the company's Billerica, MA site as an Entry-Level Quality Engineer. In this exciting role, you will support the Quality Management System (QMS) that governs the entire site’s operations. This position offers the opportunity to develop foundational experience in quality engineering while contributing to the production of life-saving medical devices.

As part of a dynamic and collaborative team, you will engage in a variety of standard quality engineering responsibilities, including CAPA support, internal/external audits, training development, and complaint investigations. You’ll work closely with cross-functional teams to drive continuous improvement and maintain the high standards of product quality and patient safety that define the company's mission.

Key Responsibilities:

• Conduct root cause analysis and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances.
• Collaborate with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to enhance product quality and process efficiency.
• Participate in risk management activities, such as Failure Modes and Effects Analysis (FMEA) for equipment and tooling.
• Support complaint investigations by analyzing lot history records and manufacturing processes.
• Support the development and execution of manufacturing change implementation plans.
• Ensure adherence to FDA, ISO 13485, and other relevant regulatory and quality system requirements.
• Document and analyze quality data to drive process improvements and operational excellence.

Must Have: Minimum Qualifications

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

Nice to Have: Preferred Qualifications

• Internship or co-op experience in a medical device, pharmaceutical, or manufacturing environment.
• Knowledge of Six Sigma, Lean Manufacturing, and process improvement methodologies.
• Experience with Good Manufacturing Practices (GMP) and regulatory compliance.
• Strong analytical and problem-solving skills.
• Ability to work collaboratively in a team environment.
• Basic knowledge of quality systems, statistical analysis, and process validation.

Effective communication skills for documentation, reporting, and cross-functional collaboration.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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