Post Market Senior Quality Engineer (Hybrid - Acton, MA.)

Insulet Corporation; Massachusetts; Hybrid; USD 68,000 - 104,000; Full time

Job summary

An established industry player is seeking a Post Market Senior Quality Engineer to ensure compliance with quality standards and regulations. This hybrid role requires collaboration across teams to enhance quality initiatives and support product safety and efficacy. The ideal candidate will have a strong background in risk management and quality systems, particularly in regulated environments. If you are passionate about improving medical device quality and enjoy working in a dynamic team setting, this opportunity is perfect for you. Join a company that values innovation and diversity in the medical field.

Qualifications

• 3-5 years of experience in a regulated environment.
• Bachelor's degree in engineering or equivalent experience.

Responsibilities

• Review and support Risk Management activities.
• Lead investigations supporting CAPAs and quality issues.

Skills

Risk Management

Problem Solving

Quality System Regulation (QSR)

ISO 13485

ISO 14971

Statistical Methods

Technical Report Writing

Education

Bachelor’s degree in engineering

Master’s degree in engineering

Tools

Word Processing Software

Spreadsheet Software

Database Programs

Job description

Post Market Senior Quality Engineer (Hybrid - Acton, MA.)

Join to apply for the Post Market Senior Quality Engineer (Hybrid - Acton, MA.) role at Insulet Corporation.

The Post Market Senior Quality Engineer is responsible for ensuring new products conform to the Insulet Quality System, Quality System Regulation, ISO 13485, and ISO 14971. He/she maintains strong collaboration with cross-functional teams and serves as a Quality representative to enhance awareness, visibility, and communication on quality initiatives, supporting departmental, functional, and corporate goals. Effective communication across all organizational levels is essential.

Responsibilities

• Review, revise, and support Risk Management activities in compliance with Quality System Regulation, ISO 13485, and ISO 14971.
• Provide guidance to ensure country-specific compliance with laws and regulations for targeted markets.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Lead investigations supporting CAPAs and other areas of the Quality System.

Education and Experience

• Bachelor’s degree in engineering, a technical or scientific discipline, or an equivalent combination of education and experience.
• 3-5 years of experience in a regulated environment.

Preferred Skills and Competencies

• Experience with QSR Part 820, ISO 13485, and ISO 14971.
• Knowledge of methods and standards for design, verification, and validation of medical devices.
• Experience with statistical methods, including SPC, sampling plans, gauge R&R, and DOE.
• Proficiency with word processing, spreadsheets, and database programs.

Additional Skills

• Master’s degree in engineering or a related scientific discipline is preferred.
• Strong verbal and written communication skills, including technical report writing.
• Ability to collaborate effectively across multiple organizational levels.
• Excellent organizational, record-keeping, and follow-up skills.
• Strong problem-solving and root cause analysis skills.

Note: This position offers a hybrid work arrangement, requiring on-site presence at least once a week in Acton, MA, with remote work possible on other days.

Additional Information

The US base salary range for this role is $68,700 - $103,050, determined by role, level, location, skills, experience, and education. Details about specific salary ranges will be shared during the hiring process.

Insulet Corporation is dedicated to innovation in medical devices, notably through its Omnipod product platform, which offers a tubeless, wearable insulin delivery system. The company values diversity and equal opportunity employment.