Quality Engineer I

Begin an impactful career at 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 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.

Requirement:

The ideal candidate will possess the following:

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.

• Top 3 technical skills that are required for the role:
oExperience in a medical device or pharmaceutical environment
oExperience with Good Manufacturing Practices and regulatory compliance.
oExperience with root case analysis.
oN/A - looking for an entry level engineer - no technical skill requirements

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

• Years' Experience Required: 0-5 yrs

Benefits:

Benefits
Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.

Compensation
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.

Work Authorization
ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.

ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.