Global Post-Market Quality & Strategy Lead

WSA – Wonderful Sound for All

gmina Komorniki

On-site

PLN 180,000 - 300,000

Full time

3 days ago

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Job summary

WSA – Wonderful Sound for All seeks a Global Post Market Quality Program Lead to drive strategic post-market quality initiatives, lead complex investigations and strengthen governance across the organization.

You will collaborate with Quality, Regulatory Affairs, R&D, Manufacturing and Supply Chain to translate priorities into actionable programs, monitor progress, and deliver measurable improvements in product quality and compliance across global teams.

Qualifications

Advanced degree in Engineering, Life Sciences or a related field.
10+ years of experience in the medical device industry, with strategic program leadership.
Strong expertise in product quality, quality systems, regulatory compliance and product risk management.
Experience leading complex cross-functional programs in a global, matrixed environment.
Experience with complex product investigations, CAPAs or other post-market quality activities.
Experience applying continuous improvement methodologies such as Lean, Six Sigma or Kaizen.
Project or program management certification is an advantage.
Experience working with multiple global teams and stakeholders is an advantage.

Responsibilities

Define, lead and execute cross-functional post-market quality improvement and governance programs aligned with corporate strategy.
Translate business and quality requirements into clear, actionable improvement initiatives and processes.
Provide strategic guidance on continuous improvement methodologies and support capability building across the organization.
Drive initiatives focused on process optimization, product reliability, post-market product performance and compliance.
Establish clear program objectives, priorities, milestones and measures of success.
Monitor program progress, identify risks and dependencies, and drive timely resolution of issues.
Promote sustainable improvements and ensure initiatives deliver measurable impact on product quality, efficiency and compliance.
Lead and facilitate complex post-market investigations related to product quality, safety, performance and regulatory compliance.
Ensure investigations are structured, evidence-based and focused on identifying systemic root causes.
Drive timely resolution of critical product issues while maintaining transparency with stakeholders.
Support the development and implementation of corrective and preventive actions.
Ensure investigation outcomes are translated into sustainable improvements and, where appropriate, broader organizational learning.
Partner with Quality, Regulatory Affairs, R&D, Manufacturing, Supply Chain and other functions to align improvement initiatives.
Facilitate cross-functional workshops, steering committees and governance forums.
Build relationships across global teams and support alignment on priorities and actions.
Drive collaboration and accountability across functions and stakeholders.
Support harmonization of processes and sharing of best practices across global teams.
Mentor colleagues in applying structured approaches to complex problems.
Act as a change agent and foster a culture of collaboration, accountability and continuous improvement.
Ensure post-market programs align with medical device regulations and internal requirements.
Stay informed about regulatory developments and assess their impact on processes.
Support audit readiness and address compliance gaps.
Integrate quality and compliance into improvement programs.
Work with stakeholders to translate regulatory requirements into practical processes.
Support maintaining high standards of product quality and safety.