Process Excellence Manager - CAPA

PhilipsMurrysville, PA
$127,000 - $202,000Onsite

About The Position

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.

Requirements

  • 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.
  • Expertise in supporting process deployment and validating root cause 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 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.
  • 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.
  • For this position, you must reside in or within commuting distance to Murrysville, PA.

Nice To Haves

  • 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.

Responsibilities

  • 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.

Benefits

  • generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • stock purchase plan
  • education reimbursement
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