Compliance Quality Engineer

Compliance Quality Engineer

Your role:

• Drive and/or own corrective and preventive actions.
• Lead cross-functional problem-solving sessions to address significant QMS issues utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
• Work cross-functionally with global stakeholders to ensure timely resolution of all CAPAs.
• Report to senior management on status of CAPAs.
• Be ambassador of the Philips quality policy within the organization.
• Monitor identify escalate and potentially lead Quality improvement efficiency initiatives in commercial operations
• Participate in continuous improvement initiatives within the QMS proposing and implementing enhancements to processes tools and systems to drive overall quality performance and operational excellence.
• Take ownership of basic processes in the assigned area/areas to ensure that QMS is efficient and meets the regulatory requirements.

Youre the right fit if:

• You have a Bachelors / Masters Degree in Mechanical Engineering Industrial Engineering Science or equivalent.
• You have minimum 5 years of CAPA experience in highly regulated environments/industries such as medical devices Pharma Automotive.
• You have minimum 3 years of experience in managing product and/or process risk assessments per ISO 14971
• You have led quality improvement projects on cost of non/poor quality
• You have a proactive and entrepreneurial mindset and act fast on potential issues.
• You have extensive experience in working with commercial functions and service/installation functions within the organization.
• You are able to deal with stakeholders and teams based globally.
• You have ASQ CQA CQE or similar credentials (e.g. Lead Auditor Lean Six Sigma) acceptable

Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development Projects Requirements Analysis Software Design Software Implementation Efficient Build Release Process and turnkey software V & V Services. We have more than 20 years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment connected vehicles Cyber security OTA and Advanced Safety/ Body electronics.