QMS Specialist

Job Title

QMS Specialist

Job Description

QMS Specialist

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.
• Proven experience in Quality Management System processes, CAPA, 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 culture.

Philips Transparency Details

The pay range for this position in Cambridge MA is $104,000 to $130,000, 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 pur