Principal Quality Systems Engineer IVDR
Waltham, Massachusetts | Boston, Massachusetts | Hopkinton, Massachusetts
ResponsibilitiesLocation Waltham, MassachusettsUS Job ID JR-023886
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
Work on a team project that focuses on new IVDR 2017/746 regulations and key changes. This includes process in technical documentation and Post Market Surveillance and Risk Management. Main duties are to develop and write technical documentation with the collaboration and strategic direction of project stakeholders. Ensure Quality system requirements are adhered to across the contributing businesses. In addition, develop training plan for newly created documentation with the global Quality systems team.
- Responsible for collaborating with business partners to determine and execute procedural requirements against EU’s IVDR.
- Understand evolution and harmonization between MDR and IVDR with
- Harmonize site level documentation to a Global PerkinElmer process, where beneficial and lead procedure and protocol work with hands-on development required
- Develop policies, procedures and work instructions based on experience in an in vitro diagnostic environment.
- Enable functions to work efficiently under clear guidance from Quality Systems strategy.
- When required, support regulatory requirements including any site inspections
- Follow project guidelines and implement under cross-function teams across the globe.
- Assure adherence to budgets, schedules, work plans, and performance requirements
- Develop and foster strong relationships with key stakeholders within the facility and within broader PerkinElmer
- Conduct Training on new requirements and procedures
- Actively participate in business review meetings as required
- Other duties as assigned
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
Bachelor’s or Master’s Degree in Engineering or Life Sciences.
5+ years of work experience in a regulated environment within the In-vitro Diagnostics or Medical Devices industry.
Strong technical writing skills for technical document creation.
Strong problem-solving skills and attention to detail
Able to collaborate effectively in a team environment, and to lead critical project tasks to completion and/or resolution
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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