Spectranetics

Process Excellence Manager - CAPA

Spectranetics$127K — $202K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in process excellence within the medical device industry or regulated environments.
  • Expertise in process deployment and CAPA-related corrective action validation.
  • Proven ability to influence and lead cross-functional teams without direct authority.
  • Strong proficiency in MS Office, Planisware, Clarity, QlikView, Windchill, and/or SAP.
  • Bachelor's or Master's degree in Engineering, IT, Business Administration, Project/Program Management, or equivalent.

Responsibilities

  • Develop and execute strategic plans for process improvement and operational excellence.
  • Author and optimize procedures to ensure regulatory compliance and quality standards.
  • Lead training and development initiatives for cross-functional teams.
  • Identify and implement process optimization and digitalization opportunities.
  • Monitor process performance and leverage data insights for continuous improvement.
  • Champion cultural change initiatives and influence stakeholders for new processes.

Benefits

  • Generous paid time off (PTO) policy.
  • 401k plan with up to 7% company match.
  • Health Savings Account (HSA) with company contributions.
  • Employee stock purchase plan available.
  • Education reimbursement for further development.
Full Job Description
Job Title
Process Excellence Manager - CAPA

Job Description

Your role:
  • Developing and executing strategic plans for the deployment, adoption, and continuous improvement of processes, tools, and methodologies, leveraging project outcomes, CAPA findings, audit observations, and business insights to drive operational excellence.
  • Authoring, reviewing, and optimizing procedures, work instructions, and process documentation to ensure clarity, consistency, regulatory compliance, and alignment with applicable quality standards, regulatory requirements, and corporate policies.
  • Leading the training, coaching, and development of cross-functional teams and stakeholders, driving process adherence, capability building, and a culture of continuous improvement across the organization.
  • Identifying, evaluating, and implementing opportunities for process optimization, standardization, digitalization, and automation through the effective utilization of enterprise toolsets, including the Philips Integrated Landscape (PIL) ecosystem.
  • Monitoring process performance, analyze project execution outcomes, and leverage data-driven insights to identify gaps, improve process effectiveness, and enhance organizational efficiency and compliance.
  • Championing organizational and cultural change initiatives by influencing stakeholders, driving adoption of new processes and ways of working, and fostering a culture of accountability, quality, and operational excellence.


You're the right fit if:
  • You've acquired 5+ years of experience driving process excellence, leading initiatives from concept through development, launch, and lifecycle management. Experience within the medical device industry or other regulated environments is required.
  • Your skills include:
    • Expertise in supporting process deployment and validating root causes and corrective actions related to consent decrees or CAPAs.
    • Proven ability to lead and influence cross-functional teams, driving alignment, decision-making, and execution across organizational boundaries without direct authority.
    • Strong knowledge of MS Office tools and Planisware, Clarity, QlikView, Windchill and/or SAP.
  • You have a Bachelor's or Master's degree in Engineering, IT, Business Administration, Project/Program Management or equivalent field of study, or 9+ years of above-related experience.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • You're an excellent communicator, both written and verbal.


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 PA is $127,000 to $202,000.

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 Murrysville, PA.

#ConnectedCare

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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