Global Process Owner, Quality Management Systems - Post Market Compliance

Requisition ID:  32883  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

The Global Process Owner QMS – Post Market Compliance is a pivotal role that significantly advances the mission to make a meaningful impact in the medical device industry. This position provides leadership in monitoring, maintaining, and continuously improving processes and supporting technology related to Quality Management System (QMS) elements. As a key process owner within the organization, the role is responsible for communicating and contributing to the development of Terumo BCT’s standardized QMS best practices. It involves developing and implementing strategies that ensure compliance with regulatory requirements while maintaining integrity and effectively managing change across the global organization. In handling post market compliance, this role drives quality excellence and contributes to significant societal impact through healthcare innovations.

ESSENTIAL DUTIES

• Process Ownership and Expertise
  • Serve as the global process owner, ensuring adherence to global regulations, standards, and processes.
  • Spearhead processes aligned with regulatory requirements and industry best practices.
  • Develop and maintain processes for tracking and analyzing post-market data to identify trends and potential areas for improvement.
  • Create and update policies and procedures to ensure compliance with regulatory requirements and industry best practices.
  • Serve as the primary contact for internal/external stakeholders on complaints management.
  • Communicate updates, resolutions, and preventive measures as needed.
• Post Market Activities
  • Oversee and manage global post-market surveillance activities to ensure compliance with regulatory requirements.
  • Lead the investigation and resolution of product complaints, ensuring timely and effective corrective actions.
  • Ensure all documentation related to post-market activities is accurate, complete, and readily accessible for audits.
• Strategic Planning and Improvement
  • Strategically plan future enhancements for QMS efficiency.
  • Evaluate technology solutions applicable to streamline processes.
  • Improve data visibility enhancing overall customer experience.
  • Implement change management strategies to align with best demonstrated practices.
  • Drive initiatives to enhance the efficiency of complaints management processes.
  • Implement feedback loops to capture lessons learned for process enhancements.
• Collaboration and Communication
  • Work closely with regulatory affairs to update processes in line with regulatory changes.
  • Lead conversations with customer service, quality assurance, legal, and product development teams to align complaint resolution processes.
  • Collaborate with cross-functional teams to document needs across departments and regions.
  • Communicate effectively to influence stakeholders and enhance understanding of QMS processes.
  • Serve as the primary contact for internal/external stakeholders on complaints management.
  • Communicate updates, resolutions, and preventive measures as needed.
• Performance Measurement and Training
  • Establish KPIs to evaluate quality system effectiveness.
  • Analyze complaint data to identify trends, root causes, and improvement areas.
  • Generate regular reports for management review highlighting key metrics and insights.
  • Establish mechanisms for monitoring/auditing complaint handling activities ensuring adherence to quality standards.
  • Develop process workflows, procedures, and training materials for global deployment.
  • Develop training programs to ensure complaint management resources are well-equipped for their tasks.
• Implementation and Issue Resolution
  • Coordinate communication between business functions, site process owners, and leadership for process changes.
  • Manage QMS-related issues promptly for effective resolution.
  • Identify risks associated with complaint handling including reputational, compliance, and financial impacts.
  • Establish escalation paths for complex/high-priority complaints ensuring timely resolution/executive attention when necessary.
  • Champion the voice of the customer by advocating for their needs within the organization.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree in a relevant engineering or scientific field required.

Experience

• A minimum of 10 years in roles related to Quality, Regulatory Affairs, Manufacturing, or Engineering within a regulated industry such as medical devices or pharmaceuticals.
• Proven track record in interpreting and applying global regulations and standards for Quality Management Systems (QMS), including FDA, ISO, EU MDR, and other quality requirements pertinent to medical devices and combination products.
• Demonstrated experience in working with, influencing, and/or leading global teams.
• Hands-on experience with electronic document management systems.
• Significant experience in a manufacturing environment is highly preferred.

Skills

• In-depth knowledge of working within a Quality Management System (QMS) framework.
• Expertise in integrating QMS elements to align with organizational expectations and meet regulatory requirements.
• Demonstrates strong strategic thinking with the ability to develop, implement, and maintain a globally standardized Quality Management System (QMS) process.
• Exhibits exceptional leadership abilities, along with effective communication and interpersonal skills.
• Possesses a growth mindset and is capable of challenging the status quo to drive continuous improvement.
• Skilled in working collaboratively and influencing stakeholders across various levels of the organization.
• Encourages open communication by actively soliciting and valuing others' ideas, contributing to a supportive work environment.
• Shows flexibility and adaptability in managing multiple topics simultaneously to fulfill business objectives.
• Proven track record of collaborating effectively with peers to enhance QMS processes and related tools.
• Proficient in using relevant PC software applications, including PowerBI, to maximize efficiency.

LOCATION

Lakewood, Colorado - Open to candidates willing to relocate to the area. 

TRAVEL

International travel is required 25% of the time.

PHYSICAL REQUIREMENTS

• Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:  $107,000.00 to $133,800.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.