JOB DESCRIPTION
Job Title Sr QMS Engineer Job Description Maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize PD's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic).
Your role: Ensures external and internal audit readiness and local leads for external and internal audits
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
Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure
Actively assists in managing Philips Intra-Company Quality Agreements
You're the right fit if: You've acquired 2+ years of experience in medical device or another regulated industry and in the application of automated technology, specifically GAMP 5
Your skills include proven experience in Quality Management System processes including cross sector or business process standardization; experience in CAPA activities; advanced analytical and project management skills; understanding of and application of 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.
You have a bachelor's degree in engineering or related field
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 an strong communicator with the ability to prioritize/manage multiple projects/programs simultaneously
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 .
Philips Transparency Details The pay range for this position is $89,376 to $153,216, annually. The actual base pay offered may vary 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.
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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.
