QMS Engineer

Job TitleQMS Engineer

Job Description

You will support sites within Image Guided Therapy Device business in continuous maintenance and improvement of the Quality Management System and its subsystems.

Your role:

• Serve as the QMS SME and be the main point of contact for QMS questions

• Support internal/external audits and respond to audit findings

• Manage annual SOP reviews and complete any required updates identified during review, redline SOPs for updates, manage/transfer any paper records

• Coordinate Management Review (Slide creation, host meeting, meeting minutes, archive record)

• Own CAPAs and quality plans, assist with other related project tasks (office closure, integration), support record migration into Windchill

You're the right fit if:

• You’ve acquired 3+ years of experience in a medical device or highly regulated industry- focusing in quality functions preferred

• Your skills include basic understanding of global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485 and ISO9001, class III combination device is highly preferred, proficiency with computers including Microsoft Office and Material/Doc Control software

• You have a Bachelor of Science (BS)

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

• You’re a strong communicator both verbally and written

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role - Plymouth

Philips Transparency Details

The pay range for this position in MN is $59,535 to $102,060

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.