Job Title
QMS Manager

Job Description

In this role you

You are responsible for supervising the QMS team, ensuring efficient execution of quality management system (QMS) activities in compliance with company policies.

Your role:
• Supervises day-to-day operations of the QMS team, ensuring all quality processes are executed efficiently and in compliance with company policies and other necessary requirements. Guides and mentors the QMS team, actively contributing to employee selection, performance management, compensation management, career development, and overseeing operational processes.
• Manages the deployment and maintenance of QMS processes in the assigned area/ areas such as document control, training, and internal audits, ensuring they are effective, compliant, and aligned with both regulatory requirements and business needs.
• Monitors and reports on the effectiveness of QMS processes by analyzing performance metrics, identifying trends, and developing action plans to address gaps, enhance compliance, and improve overall quality.
• Prepares for and supports external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings. Manages the documentation and resolution of non-conformance reports (NCRs), ensuring systematic tracking, effective resolution, and implementation of preventive measures to avoid recurrence.
• Conducts risk assessments and manages risk mitigation activities, identifying potential risks to product quality and QMS integrity, and developing strategies to minimize their impact.

You're the right fit if:

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
3+ years of experience with Bachelor's in areas such as Quality Engineering, Quality Management Systems, Process Engineering or equivalent
We prefer 5+ years of experience with medical device regulations and standards, QMS Management, QMS Remediation, Hosting Quality Audits, CAPA, Root Cause Analysis, Data Analysis.
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.

The pay range for this position in Cambridge MA is $102,000 to $143,400 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

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.

Spectranetics

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QMS Manager