Supplier Quality Engineer - Acton, United States - Insulet Corporation

Insulet Corporation Acton, United States

3 weeks ago

Description

Supplier Quality Engineer (On-site) page is loaded

Supplier Quality Engineer (On-site)

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locations

Acton, Massachusetts

time type

Full time

posted on

Posted Yesterday

job requisition id

REQ

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform.

In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

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
This

Supplier Quality Engineer

is responsible for Design Control to ensure current products and new projects meet the regulatory and quality requirements for medical devices.

Interfaces with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support.

Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.

Responsibilities:

Responsible for Design Control initiatives to develop appropriate Design History File documents. Review and approve new product documentation, as required.
Collaborate with Project Management to optimize Design Control process and develop Sustaining Quality Engineering process.
Review and approve Design Control documents and protocols.
Serve as the Design Control expert to organization.
Develop and deliver Design control training for organization.
Support CAPA activities
Support Risk Management activities and ensure compliance to standards and regulation
Performs other duties as assigned.

Education and Experience:

Minimum Requirements:

BS degree, in an

engineering/scientific/computer

systems/ or quality management curriculum or equivalent experience.

A minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
Experience in the development and implementation of effective Design Control Systems.
Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices.
Working knowledge of EN 60601, Safety requirements for medical electrical systems.
Working knowledge of ISO 62304, Medical Device Software – Software Life Cycle Process
Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).
Demonstrated experience organizing and maintaining large documentation sets.
Ability to follow up with task owners to close out open items.
Familiarity with structured phase-gate product development processes.
Familiarity with FDA, ISO, and other international regulatory requirements.

Preferred Skills and Competencies:

Effective verbal and written communication skills.
Experience collaborating and communicate with individuals at multiple levels in an organization.
Ability to organize and judge priorities.
Ability to generate and maintain accurate records.
Skilled in computer use including word processing, spreadsheet, and database applications.
Able to work effectively in a high-stress, high-energy environment.

Physical Requirements:

Travel as required to support business needs

NOTE:
This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

The US base salary range for this full-time position is $65, $98, 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.

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 )

Insulet Corporation is proud to be an equal opportunity employer.

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.

Insulet employees are all focused on the same goal —

to make a difference. Our relentless passion is to simplify life for people with diabetes.

We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance.

We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there.

We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers.

Our innovation spirit and customer-centric focus position us as global pioneers —

leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.

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