Spectranetics

Ultrasound QMS Director

Spectranetics$180K — $252K *
Healthcare
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  • 8+ years of experience (Bachelor's) or 6+ years (Master's) in Quality Management Systems, Quality Audits in regulated environments.
  • Preferred 7+ years of leadership experience in complex matrix organizations.
  • Strong background in document control, internal audits, CAPA, and training programs in QMS.
  • Proven ability to manage regulatory inspections and audits effectively.

Responsibilities

  • Oversee QMS functions, ensuring effective implementation and compliance.
  • Collaborate with senior leadership to align quality strategy with business goals.
  • Manage regulatory inspections and audits, acting as key contact for auditors.
  • Analyze QMS data to identify issues and lead quality improvement initiatives.
  • Provide expert guidance on quality-related risks and compliance to executive leadership.

Benefits

  • Generous PTO and holiday time off.
  • 401(k) plan with up to 7% company match.
  • Health Savings Account (HSA) with company contributions.
  • Employee stock purchase plan and education reimbursement.
  • Participate in a comprehensive benefits program that enhances overall wellbeing.
Full Job Description
Job Title
Ultrasound QMS Director

Job Description

Ultrasound QMS Director

In this role you

Are responsible for overseeing the strategic management of the QMS department, aligning it with organizational goals and industry best practices.

Your role:

• Manages and oversees multiple QMS functions, such as document control, internal audits, CAPA, and training programs, ensuring their effective implementation, compliance, and continuous improvement across the organization.
• Collaborates with senior leadership to influence and align quality strategy with business objectives, ensuring that quality management processes support operational efficiency, risk management, and strategic growth.
• Oversees the preparation and execution of regulatory inspections and external audits, acting as the key point of contact for auditors, and managing the response to findings to ensure timely and effective resolution.
• Oversees the analysis of complex QMS data and trends across multiple functions to identify systemic issues, leads cross-functional teams in root cause analysis, and drives the implementation of strategic quality improvement initiatives.
• Acts as a key advisor on quality-related risks and opportunities, providing expert guidance to executive leadership on regulatory changes, compliance risks, and quality trends to inform strategic decision-making.
• Takes responsibility for planning, staffing, budgeting, managing priorities, and proposing/implementing methodological changes for a function/region/business.

 

You're the right fit if:

  • Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  • 8+ years of experience with Bachelor's OR 6+ years of experience with Master's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.
  • Prefer 7+ years of experience in leading teams with direct and indirect reports in complex matrix organizations and delivering on organizational objectives.
  • 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.

Philips Transparency Details

The pay range for this position in Cambridge, MA is $180,600 to $252,000 Annually. 

The pay range for this position in Bothell, WA is $180,600 to $252,000 Annually. 

The pay range for this position in Reedsville, PA is $180,600 to $252,000 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, Bothell WA, Reedsville PA.

#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.

About Spectranetics

Spectranetics is a medical device company that develops, manufactures, and markets single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company's products include laser atherectomy systems, thrombectomy systems, and lead management accessories. Spectranetics was founded in 1984 and is headquartered in Colorado Springs, Colorado. In 2017, the company was acquired by Royal Philips for $2.2 billion.
Learn more about Spectranetics
Size
900 employees
Industry
Founded
1980

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