Sr Quality Engineer

Careers that Change Lives
A Day in the Life
Summary 
The System Quality Engineer is accountable for supporting risk management activities for new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control and other regulatory requirements.
Primary Responsibilities

 

Provide Risk Management technical expertise through the product life cycle for new product development projects and platforms.

 

       Product Requirements management and Design Validation

       Provide guidance to the team on risk management, regulatory and Quality Engineering policies, principles, and best practices.

       Facilitate development and completion of risk management deliverables between systems by collaboratively working with quality, R&D, engineering, marketing and clinical.

       Develop and maintain Risk Management Files according to ISO (International Standards Organization) 14971 and ensure Risk Management Files are updated per defined schedules and

 Frequencies.

 

 

Required Skills and Knowledge 

       Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR, EN ISO 14971:2012, IEC 60601-1, ISO 13485, EN 62304, IEC 62366, FDA Guidance - Cyber Security, interoperability, assurance cases etc.) to the R&D environment

       Teamwork oriented and ability to lead and influence with proven problem-solving skills

       Consistent application of technical principles, theories, concepts, and quality sciences / tools and demonstrates knowledge of FDA/ISO requirements

       Excellent communication and writing skills, this role will require writing quality reports and presentations for executive management and auditors

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

       Direct experience with medical devices in a regulatory environment

       Medical Device hardware/software/disposables experience is preferred

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.

The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc. 
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)