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

Insulet Corporation; Acton (MA); Hybrid; USD 68,000 - 104,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Post Market Quality Engineer in Acton, MA who is responsible for quality assurance tasks. The ideal candidate will handle documentation processing, investigations, and compliance with regulatory standards. This role requires a BA/BS degree and minimum two years of related experience in a regulated industry.

Qualifications

• Minimum 2 years experience in an engineering and/or quality role.
• Knowledge of FDA regulations and QMS.
• Experience leading improvement projects is a plus.

Responsibilities

• Responsible for processing documentation and conducting investigations.
• Ensure compliance with Quality Management System activities.
• Develop and deliver training for organization.

Skills

Attention to Detail

Problem Solving

Verbal Communication

Technical Writing

Organizational Skills

Education

BA/BS Degree

Tools

Microsoft Office

Job description

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

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

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

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

The Post Market Quality Engineer position is responsible for quality activities to ensure current process requirements are met. Interfaces with other Insulet departments (e.g. Operations, and Information Technology, Engineering, and Regulatory Affairs) as well as other external parties on issues related to product support. Effectively processing documents and protocols and ensuring ambiguities and conflicting requirements are resolved.

Responsibilities

• Responsible for processing of documentation in specified tool.
• Responsible for processes and systems.
• Conduct investigations and root cause analysis.
• Review and approve documentation, as required.
• Responsible for QMS activities: quality events, CAPAs, deviations, etc.
• Develop and deliver training for the organization.
• Support Risk Management activities and ensure compliance with standards and regulations.
• Responsible for metrics development and compliance with team targets.
• Performs other duties as assigned.
  
  

Minimum Requirements

• BA/BS Degree required.
• Minimum 2 years experience in an engineering and/or technical quality/compliance role within a regulated industry.
  
  

Preferred Skills And Competencies

• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 – Application of risk management to medical devices.
• Demonstrated experience organizing and maintaining large documentation sets.
• Ability to follow up with task owners to close out open items.
• Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization.
• Knowledge of Microsoft Office programs (e.g. Word, Excel, and PowerPoint)
• Ability to organize and judge priorities.
• Strong attention to detail with excellent grammatical, editorial, and proofreading skills.
• Project management skills: timelines, ownership, drive accountability, etc.
• Experience leading/managing improvement projects.
• Ability to problem solve / conduct root cause investigations.
• Periodic travel may be required.
  
  

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).

Additional Information

The US base salary range for this full-time position is $68,700.00 - $103,050.00. 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.

(Know Your Rights)

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Insulet Corporation by 2x

Sign in to set job alerts for “Quality Engineer” roles.

Bedford, MA $115,000.00-$145,000.00 3 weeks ago

GMP operational Quality, Senior Specialist - Quality Engineer(contract) 25421

Bedford, MA $100,000.00-$200,000.00 3 weeks ago

Nashua, NH $90,000.00-$120,000.00 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.