QMS Engineer - Philips
Plymouth, MN
About the Job
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 .
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
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 .
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.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
Source : Philips
