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QMS Compliance Lead

2 months ago

Latham, United States Philips North America Full time

Job TitleQMS Compliance Lead

Job Description

The QMS Compliance Lead ensures the facility operates in compliance with its established Quality Management System, confirming product compliance according to applicable standards and requirements prior to distribution to Philips system manufacturing facilities and customer sites.

Your role:

  • The QMS Compliance Lead is responsible for document management, training administration, process improvement, and execution of QMS procedures and work instructions to ensure processes and changes are executed in a controlled manner and in compliance with applicable regulations.

  • To be effective in this position, this individual will be knowledgeable in and able to train to all areas of a QMS including but not limited to corrective and preventive action, non-conforming material control, audit preparation, customer feedback, supplier management, and change control.

  • This individual is a member of the Operations Quality team in Latham and works closely with Area Managers, Team/Group Leads and Quality Engineers (QEs) to ensure compliance with legal, regulatory, and international standards as they apply to Lathams Quality Management System.

  • Develop expertise regarding maintaining and sustaining a compliant medical device QMS, including its various functions, systems, and processes, while networking with cross-functional team members and functional leaders.

You're the right fit if:

  • Youve acquired 3+ years of experience in medical device (preferred) or a regulated industry (e.g. aerospace, automotive).

  • You have experience working in a Quality Management System compliant with ISO 9001, ISO 13485, and/or FDA CRF 21 part 820, and Good Manufacturing Practices (GMP). Must be highly proficient with Microsoft Office applications; experience with eQMS (Trackwise, EtQ) and ERP (SAP) software desired.

  • You have a Bachelors Degree, or an Associates Degree with relevant work experience.

  • Youre an individual with strong attention to detail and strong communication skills including written, verbal and listening. You also possess excellent organizational skills with the ability to multi-task and effectively prioritize your workload.

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

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 youre 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 $56,700 to $97,200, 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 Phillips-Latham.

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.