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

Insulet in; Acton (MA); Hybrid; USD 85,000 - 128,000; Full time

Job summary

A leading company in medical devices seeks a Senior Quality Engineer to ensure product compliance with quality standards. This hybrid position requires collaboration with cross-functional teams and expertise in managing quality initiatives. If you are motivated and driven, consider joining us to make an impact in diabetes management.

Qualifications

• 3+ years of experience in regulatory quality/compliance engineering.
• Knowledge of QSR Part 820 and ISO 13485.
• Strong verbal and written communication skills.

Responsibilities

• Ensure new products conform to the Insulet Quality System.
• Lead investigations supporting CAPAs and other quality areas.
• Review and revise Risk Management activities.

Skills

Communication

Problem-Solving

Quality Assurance

Statistical Methods

Project Management

Education

BS degree in engineering or related discipline

Master's degree in engineering or related scientific discipline

Tools

Word Processing

Spreadsheets

Databases

Job description

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

The Senior Quality Engineer, Post Market 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 promote awareness, visibility, and communication on quality initiatives supporting departmental, functional, and corporate goals. Effective communication across all organizational levels is essential.

Responsibilities:

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

Required Qualifications:

1. BS degree in engineering, a technical or scientific discipline, or an equivalent combination of education and experience.
2. At least 3 years of experience in an engineering or technical quality/compliance role within a regulated environment.

Preferred Qualifications:

1. Master's degree in engineering or a related scientific discipline (preferred).
2. Experience with QSR Part 820, ISO 13485, and ISO 14971.
3. Experience in design, verification, and validation of medical devices.
4. Knowledge of statistical methods such as SPC, sampling plans, gauge R&R, and DOE.
5. Proficiency with word processing, spreadsheets, and databases.
6. Strong verbal and written communication skills, including technical report writing.
7. Ability to organize, prioritize, and maintain accurate records.
8. Ability to follow up on open items and resolve issues efficiently.
9. Excellent problem-solving and root cause analysis skills.

Note: This position is hybrid, requiring at least three days per week on-site at an Insulet office. #LI-Hybrid

Additional Information: The US base salary range is $85,125 to $127,687.50, based on role, level, and location. Compensation includes base salary, with potential bonuses, equity, and benefits, depending on individual factors. More details will be provided during the hiring process.

Insulet Corporation, NASDAQ: PODD, is dedicated to innovating medical devices for diabetes management, including the Omnipod product platform and the Omnipod 5 Automated Insulin Delivery System. For more information, visit insulet.com and omnipod.com.

We seek motivated, performance-driven individuals to join our team, guided by shared values and a commitment to exceeding customer expectations. Our success depends on talented people like you!

Insulet is an equal opportunity employer, considering all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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