Spectranetics

QMS Manager

Spectranetics$134K — $186K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's/Master's Degree in Mechanical or Industrial Engineering, Science, or equivalent.
  • 5+ years of experience in Quality Management Systems or Quality Audits within highly regulated environments such as Medical Devices, Pharma, or Automotive.
  • 5+ years overseeing teams in complex, matrixed organizations achieving organizational objectives.
  • Ability to meet physical, cognitive, and environmental job requirements with or without accommodation.

Responsibilities

  • Analyze QMS performance data to identify trends and improvement opportunities, leading cross-functional teams to implement solutions.
  • Serve as a senior quality advisor and primary point of contact for regulatory bodies, managing compliance and external audits.
  • Lead problem-solving initiatives using advanced quality tools like Six Sigma or Lean to resolve critical quality issues.
  • Manage non-conformance reports (NCRs) ensuring thorough investigation and implementation of preventive measures.
  • Coordinate risk assessments, identifying risks to product quality and QMS integrity, and develop robust mitigation strategies.

Benefits

  • Generous paid time off (PTO).
  • 401k plan with up to 7% company match.
  • Health Savings Account (HSA) with company contribution.
  • Stock purchase plan available.
  • Education reimbursement program.
Full Job Description
Job Title
QMS Manager

Job Description

Ultrasound QMS Manager

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:

• Analyzes QMS performance data to identify trends, systemic issues, and improvement opportunities, and lead cross-functional teams in developing and implementing effective solutions to enhance quality and compliance.
• Serves as a senior quality advisor and key point of contact for regulatory bodies, ensuring that QMS processes and practices are fully compliant, and effectively managing external audits, inspections, and follow-up actions.
• Leads and manages complex, high-impact problem-solving initiatives using advanced quality tools and methodologies such as Six Sigma or Lean, ensuring effective resolution of critical quality issues and sustainable improvements. Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Oversees the management and resolution of non-conformance reports (NCRs), ensuring systematic tracking, thorough investigation, effective resolution, and implementation of preventive measures.
• Coordinates risk assessments and risk management activities, identifying significant risks to product quality and QMS integrity, and developing and implementing robust mitigation strategies.


You're the right fit if:

  • Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
  • 5+ years of experience with Bachelor's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as Medical Device, Pharma, Automotive.
  • 5+ 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 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 $134,000 to $186,000 Annually. 

The pay range for this position in Bothell, WA is $134,000 to $186,000 Annually. 

The pay range for this position in Reedsville, PA is $120,000 to $170,000 Annually. 

The pay range for this position in Plymouth, MN is $126,000 to $175,000 Annually. 

The pay range for this position in San Diego, CA is $134,000 to $186,000 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 . 

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, Plymouth MN, San Diego CA.

#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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