Want to work for a fun, fast-paced company that is rapidly growing? If you want to be rewarded for taking charge and getting things done at a company with a more exciting story, products and co-workers, then look no further, we’ve got the job for you! The Senior Quality Engineer will partner with R&D, Operations and other internal partners in new product development as well as providing quality engineering support and leadership to the entire organization to enable us to deliver our customers with the highest quality and most reliable products. As a member of the Quality Operations Team, this position will have the primary responsibility for influencing product quality and reliability outcomes across new product development and our existing product portfolio. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
HERE'S WHY YOU’LL LOVE THIS JOB:
- You thrive in a fast pace work environment (it’s not boring).
- You love to focus on all the little details that make the big picture happen.
- You enjoy juggling competing priorities in a fast-paced environment.
- You thrive in a team-focused environment.
- You love contributing to innovation, which can be chaotic and rewarding all at once!
HERE’S WHAT YOU’LL BE DOING:
- Responsible for overseeing all risk management activities throughout the product realization process.
- Perform and/or direct completion of specific product verification/validation testing and analyses required to satisfy both regulatory and internal requirements, including the preparation of quality plans and technical reports.
- Provide support for problem solving investigations to guide root cause analysis/corrective action throughout the product realization process.
- Leads failure investigations for product complaints.
- Provide support for Supplier Management, including qualifying, auditing and performing ongoing assessments.
HERE’S WHAT YOU’LL BRING TO THE ROLE:
- Bachelor’s Degree in Engineering or Scientific field with a minimum of five (5) years related experience.
- Strong working knowledge of ISO 14971:2019 Medical devices — Application of risk management to medical devices.
- Strong working knowledge of ISO 13485:2016 and FDA 21 CFR 820 requirements for design development, usability engineering, supplier management and failure analysis.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects.
PERKS! We proudly offer full health benefits at a low cost to you. That’s medical, dental, vision, FSAs, HSAs, Accident Insurance and even Pet Insurance for your furry family to name a few. We also provide Basic Life/AD&D and Long-Term Disability coverage at no cost to you! Top these benefits off with a 401(K) plan with an Employer Match because your retirement is just as important to us. Best part about it, you will be fully vested immediately!
Every person here is a key player in our success. We are firm believers in making the little things count each day, so that the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.
We mean it when we say you’ll LOVE this role.