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

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

Job summary

A leading medical device company is seeking a Senior Quality Engineer in Acton, MA. The ideal candidate will ensure compliance with quality regulations and lead investigations, contributing to the overall quality goals of a key product platform. This hybrid role requires a strong background in engineering and quality compliance, along with excellent communication and problem-solving skills.

Qualifications

• 3 years experience in an engineering and/or technical quality/compliance role within a regulated environment.
• Experience with QSR Part 820, ISO 13485 and ISO 14971 preferred.

Responsibilities

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

Skills

Problem Solving

Communication

Collaboration

Root Cause Analysis

Education

BS degree in engineering or technical/scientific discipline

Tools

Statistical methods

Job description

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

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

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

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

The Senior Quality Engineer, Post Market is responsible for ensuring new products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative to improve awareness, visibility, and communication on all quality initiatives in order to support departmental, functional and corporate quality goals and priorities. He/she can effectively communicate with all levels of the organization.

Responsibilities

• Reviews, revises and supports Risk Management activities to Quality System Regulation, ISO 13485 and ISO14971.
• Provide guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues.
• Ability to lead investigations supporting CAPAs and other areas of the Quality System.
  
  

Required Qualifications

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

Preferred Qualifications

• Master’s degree in engineering or technical or scientific discipline preferred.
• Experience with QSR Part 820, ISO 13485 and ISO 14971.
• Experience with methods and standards for the design, verification, and validation of medical device products.
• Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments).
• Experience with word processing, spreadsheet, database programs.
• Effective verbal and written communication skills.
• Effective collaboration and communication with individuals at multiple levels in an organization.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Ability to follow up with task owners to close out open items.
• Strong problem solving / root cause analysis skills.
• Good verbal (including presentation) and written communication skills, especially technical report writing.
• Ability to generate and maintain organized and accurate records.
  
  

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week.

Additional Information

The US base salary range for this full-time position is $85,125.00 - $127,687.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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