Quality assurance leader

About the Role

The key accountability for this role is to ensure compliance of the quality management system with local Regulations and Olympus procedures covering storage, handling and distribution, complaint handling, adverse event reporting, field corrective action, audits, etc. This role provides quality leadership to safeguard product quality and patient safety through quality oversight, compliance management, and continuous improvement initiatives.

Responsibilities

• Ensure compliance with Korean medical device regulations and Olympus procedures.
• Implement effective Quality System for OKR aligned with the Olympus Quality Management System, but defining and approving truly necessary “local variances”.
• Serve as the designated Management Representative for the QMS and facilitate management review meetings. Report performance of global quality objectives and metrics to support management review process in ensuring appropriate inputs, outputs, and follow up actions.
• Lead various QMS audits, internal/external audits, and management reviews.
• Advance company QMS through monitoring of regulations and specification changes as applicable.
• Participate in the relevant interpretation of policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Lead Post-Market Surveillance including customer complaint handling, reportability assessment of adverse events occurred locally and overseas and field corrective action.
• Communicate and manage cross-functional stakeholders, including OKR leadership team, Country Leader/Managing Director, business leaders and cross-functional teams, in driving overall site performance, developing and building culture of quality and continuous improvement.
• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Drive continuous improvement - lead value-add activities, such as leading Kaizen events, facilitating pre and post-mortems, and designing/facilitating brainstorming sessions.
• Develop and execute Quality plans to address gaps.
• Manages the development and performance of team members to support business and quality objectives.
• Drive transparent KPIs to address Quality and Compliance performance.
• Set and improve Quality Culture and Customer Focus mindset across OKR.
• Plan and manage QA department budget.
• Perform other tasks as required by the line manager.

Qualifications

• Bachelor’s degree in sciences or related field.
• Minimum 10 years of experience in quality management or compliance function with at least 5-7 years of management experience in a regulated environment in the MedTech industry.
• Demonstrated comprehensive expertise in the applied interpretation of relevant regulatory standards and laws applicable to the medical device industry such as: South Korean Medical Device Act, ISO, QSR, GMP, GDP.
• Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.
• Experience with durable medical equipment and sterile disposable medical devices within Med Tech industry is strongly preferred.
• Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.
• Experience in data analysis, trending and presenting data in a manner to drive informed decision making.
• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
• "Out of box" strategic thinker with strong leadership ability.
• As a change agent, motivated to improve organization and not be satisfied with status quo.
• Experienced in initiating, cultivating and embedding a cultural change in a complex and diverse Olympus organization.

Required Skills

• Excellent interpersonal and leadership skills with diverse cultural approach.
• A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus.
• Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
• Excellent written and oral communication and organizational, project management skills.
• Proven analytic and problem-solving skills.
• Strong stakeholder management and ability to influence and coach others.

Preferred Skills

• Experience in data analysis, trending and presenting data in a manner to drive informed decision making.
• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.

Olympus is an Equal Opportunity Employer.

“We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.”