Philips
QMS Manager
Philips, Cambridge, Massachusetts, us, 02140
QMS Manager
In this role you
Maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize SRC's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic).
Your role:
Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to FDA regulations and other Regulatory Agency and consensus standard requirements
Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes; monitoring and assurance of process performance
Represents QMS/Engineering Change processes and records to regulatory agencies as required
Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule
You're the right fit if:
Bachelor’s degree plus a minimum of 3+ years of related experience in the medical device or another regulated industry and in the application of automated technology, particularly GAMP 5
Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
Experienced Engineer with proven success within teams and delivering on organizational objectives
Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
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.
This is an office role.
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.
Learn more about our commitment to diversity and inclusion.
Philips Transparency Details
The pay range for this position In Cambridge is $93,000 to $127,000, Annually.
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 Cambridge MA
#LI-PHI
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
In this role you
Maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize SRC's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic).
Your role:
Reviews QMS and Engineering changes as well as Quality plans to ensure compliance/conformance to FDA regulations and other Regulatory Agency and consensus standard requirements
Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes; monitoring and assurance of process performance
Represents QMS/Engineering Change processes and records to regulatory agencies as required
Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule
You're the right fit if:
Bachelor’s degree plus a minimum of 3+ years of related experience in the medical device or another regulated industry and in the application of automated technology, particularly GAMP 5
Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
Experienced Engineer with proven success within teams and delivering on organizational objectives
Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
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.
This is an office role.
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.
Learn more about our commitment to diversity and inclusion.
Philips Transparency Details
The pay range for this position In Cambridge is $93,000 to $127,000, Annually.
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 Cambridge MA
#LI-PHI
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