Senior Quality Specialist (Compliant Investigation)

Requisition ID: 33722

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.

As a Senior Quality Specialist (Complaint Investigation), where your expertise will directly impact patient safety and product excellence. In this pivotal role, you'll collaborate across departments to ensure compliance with FDA, ISO, and global regulatory standards, lead corrective action initiatives, and support internal and external audits. With a focus on MDR reportable complaints and complex technical investigations, this position is ideal for professionals with experience in medical device quality systems. If you're passionate about improving lives through innovation and regulatory excellence, we invite you to be part of our mission-driven team.

ESSENTIAL DUTIES

• Works with quality management, manufacturing, engineering, and other functional groups on regulatory and quality system compliance issues. Develops or participates in the development of solutions to problems of intermediate to high complexity.
• Performs varied quality/regulatory activities such as developing and implementing plans and procedures to comply with applicable local, state, federal, and international regulations.
• Interprets, executes, and recommends modifications to operating policies where appropriate. Modifies, updates, and executes established programs to achieve and maintain a state of compliance.
• Contributes toor leads projects for the timely completion of corrective actions.
• Supports the implementation and maintenance of the Quality System.
• Provides support tothe internal and external audit program.
• Leads and participates in continuous improvement.
• May participate in evaluation of complaints for adverse event reporting on a global basis and is responsible for submitting necessary reports for North America according to policies and procedures.
• May develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements and standards.
• May assist or lead in identification, creation, implementation, and maintenance of training for QMS policies and procedures.
• May prepare and deliver presentations to management team.
• May direct supervision of professional and quality support staff including the review, evaluation, and development of reporting associates.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

• Minimum 5 years experience.
• Experience with MDR reportable complaints (21 CFR 803) and requirements for report submissions.
• Experience with complex customer complaint investigation of a technical and medical nature.

Skills

• Able to orchestrate multiple activities at once under limited direction.
• Experience in process mapping.
• Strong knowledge of FDA and ISO regulations preferred.
• Ability to communicate effectively both verbally and in writing on a global basis.
• Working knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Demonstrated strong problem-solving skills.
• Detail oriented.
• Provenproject leadership and project management skills.
• Proficiency in technical writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

LOCATION

Lakewood, Colorado - Onsite (3 days) - Open to candidates willing to relocate to the area.

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:$82,700.00to$103,400.00 -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.