Global Post-Market Quality Program Lead (m/f)

WSA – Wonderful Sound for All; gmina Komorniki; On-site; PLN 180,000 - 300,000; Full time

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.

Skills

Strategic program leadership

Product quality

Regulatory compliance

Cross-functional leadership

Post-market quality

Lean Six Sigma Kaizen

CAPA investigations

Global matrix environment

Program/project management cert

Problem solving

Education

Advanced degree in Engineering, Life Sciences or related field

Tools

Job description

At WSA, patient safety and product quality are at the heart of what we do. As part of our global Quality & Regulatory Affairs organization, the Global Post Market Quality (PMQ) Program Lead plays an important role in driving strategic post-market quality initiatives, leading complex investigations and strengthening governance across the organization.

What You Will Do

The role combines strategic program leadership, complex problem solving, cross-functional collaboration and continuous improvement. You will work closely with Quality, Regulatory Affairs, R&D, Manufacturing, Supply Chain and other business functions to improve product quality, reliability, compliance and post-market performance.

As a strategic program leader, you will help translate business and quality priorities into actionable programs, establish effective governance and drive sustainable improvements across functions and global teams.

Strategic Program Leadership

• 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.

Complex Investigations

• Provide strategic oversight for complex post-market investigations related to product quality, safety, performance and regulatory compliance.
• Ensure appropriate frameworks, governance structures and tools are in place to support effective root cause analysis and problem solving.
• Lead and facilitate complex investigations involving multiple functions and stakeholders.
• Ensure investigations are structured, evidence-based and focused on identifying systemic root causes.
• Drive timely resolution of critical product issues while maintaining appropriate transparency with internal and external stakeholders.
• Support the development and implementation of effective corrective and preventive actions.
• Ensure investigation outcomes are translated into sustainable improvements and, where appropriate, broader organizational learning.

Cross-Functional Collaboration

• Partner with Quality, Regulatory Affairs, R&D, Manufacturing, Supply Chain and other business functions to align improvement initiatives.
• Facilitate cross-functional workshops, steering committees and governance forums.
• Build strong relationships across global teams and support alignment on priorities, responsibilities and actions.
• Drive collaboration and accountability across functions and stakeholders.
• Support the harmonization of processes and sharing of best practices across global teams.
• Mentor and support colleagues in applying structured approaches to complex problems and improvement initiatives.
• Act as a change agent and help foster a culture of collaboration, accountability and continuous improvement.

Regulatory & Compliance

• Ensure post-market quality programs and initiatives are aligned with applicable medical device regulations and internal requirements.
• Stay informed about relevant regulatory developments and assess their potential impact on post-market quality processes.
• Support audit readiness and proactively identify and address compliance gaps.
• Ensure quality and compliance considerations are appropriately integrated into improvement programs and investigations.
• Work with relevant stakeholders to translate regulatory and business requirements into practical and sustainable processes.
• Support the organization in maintaining high standards of product quality, safety and regulatory compliance.

Performance & Reporting

• Establish KPIs and appropriate meeting structures to monitor program effectiveness and progress.
• Develop clear and transparent reporting on program status, risks, issues, opportunities and key decisions.
• Use data and insights to support fact-based decision-making and identify opportunities for improvement.
• Prepare and deliver executive-level presentations highlighting progress, risks, opportunities and required actions.
• Ensure timely escalation of significant risks and issues to the appropriate stakeholders.
• Measure and communicate the impact of improvement initiatives on product quality, efficiency and compliance.

Experience

What you bring

• Advanced degree in Engineering, Life Sciences or a related field.
• 10+ years of experience in the medical device industry, with proven experience in strategic program or project leadership.
• Strong expertise in product quality, quality systems, regulatory compliance and product risk management.
• Demonstrated experience leading complex cross-functional programs and initiatives.
• Experience with complex product investigations, CAPAs or other post-market quality activities.
• Experience working effectively across functions in a global, matrixed environment.
• 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.

Personal competencies

• Strategic thinker with a strong results-oriented mindset.
• Excellent analytical and problem-solving skills.
• Strong ability to structure complex problems and develop practical solutions.
• Influential leader who can build alignment and accountability across functions.
• Excellent stakeholder management and communication skills.
• Able to work effectively in a global, matrixed organization.
• Comfortable navigating complex and changing regulatory and operational environments.
• Strong facilitation and presentation skills.
• Proactive, resilient and adaptable approach.
• Ability to manage multiple priorities and drive initiatives to completion.
• Strong continuous improvement mindset.
• Passionate about product quality, patient safety and operational excellence.
• Fluent English, both written and spoken.

Who We Are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

WSA is an equal‑opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status, we firmly believe that our work is at its best when everyone feels free to be their most authentic self.