Senior Medical Safety Quality Specialist

Requisition ID:  32573  

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 Senior Medical Safety Quality Specialist will act as a key member in strategic planning, management, and execution of activities concerning the safety and performance of post-market apheresis medical devices to ensure patient safety throughout the product lifecycle. This involves utilizing extensive patient-facing apheresis clinical experience and knowledge to lead and participate in safety signal identification, evaluation, and management for marketed products. The Senior Medical Safety Quality Specialist provides technical and clinical knowledge regarding product usage and performance, as it relates to patient safety, on medical devices utilized for therapeutic and donation processes. As the Senior Medical Safety Quality Specialist and subject matter expert, the incumbent works closely with cross-functional Regulatory, Quality/Post-Market Compliance, Risk Management, Customer Support and Complaint Handling teams to ensure patient safety, promoting the safe and effective use of apheresis medical devices.  Works collaboratively with Global Medical Safety team members and external physicians as needed to facilitate informed decision-making.

DUTIES AND RESPONSIBILITIES

• Provide clinical and apheresis expertise in identifying and evaluating adverse event reports and investigations. 
• Lead investigations for reportable adverse event complaints, potentially resulting in Field Action Evaluation decisions.
• Conduct evaluations of medical device performance and clinical data, assessing impact on product safety.
• Perform literature searches and initiate complaint investigations based on findings.
• Provide evidence-based medical safety input and education on safety inquiries from internal or external stakeholders (e.g., external medical personnel or other third parties, including regulatory agencies or health care organizations).
• Assist in developing product training and technical review standardization specific to adverse event incidents and complaints.
• Collaborate across functions to ensure regulatory compliance and quality system adherence.
• Physically evaluate returned disposable kits, which may contain blood product.
• Apply clinical and practical statistical methods, where applicable.
• Analyze individual and aggregate safety data to identify and communicate safety risks effectively.
• Supervise and develop team members, including review and development of reports.
• Lead continuous improvement initiatives.
• Works with quality management, manufacturing, engineering and other functional groups on regulatory and quality system compliance issues. 
• Participates in the development of solutions to problems of intermediate to high complexity.
• Provides support to the internal and external audit program.
• Critically assess and escalate newly identified safety issues (suspected increase in severity and/or frequency of known events or new events with a causal relationship to the device) per business unit processes for investigation assessment and action.
• Actively acquire and maintain knowledge of relevant scientific literature associated with assigned devices/therapies.
• Author high-quality and accurate safety assessments per business unit processes, leveraging complaint data, literature, registries, or other data sources as appropriate.
• Make competent, risk-based, and timely medical safety decisions based on analysis of critical information; able to balance analysis with decisiveness.
• Solid medical background with the ability to apply complex disease states and different treatment outcomes and complications specific to therapeutic and donation based processes.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree in nursing (apheresis preferred), biological sciences, or above.

Experience

• Licensed healthcare professional (e.g., RN, PA, NP) with at least three years of clinical experience in apheresis; or, with an advanced degree (Master’s or above, MD), at least two years of clinical experience in apheresis.
• Preferred: 3+ years relevant experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
• Preferred: 2+ years leveraging medical knowledge as an advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle.
• Preferred: Experience in transfusion medicine, blood banking, cellular therapy, and/or apheresis.
• Knowledge of ISO 13485, FDA CFR 21 Part 820, ISO 14971, MDR, and Vigilance reporting.

Skills

• Strong knowledge of the physiology and clinical practice of the relevant therapies.
• Understanding of experimental design and medical statistics.
• Knowledge of root cause analysis investigation tools.
• Knowledge of FDA regulations and Good Clinical Practices.
• Able to orchestrate multiple activities at once under limited direction.
• 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 problem-solving and project management abilities.
• Detail-oriented with proficiency in technical writing and PC applications.
• Excellent communication skills for global interactions.
• Proficiency in root cause analysis and clinical methods.

-Or-

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

LOCATION

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

• On-site position with flexible hybrid schedule, dependent on the necessity to support adverse event complaints.
• There will be occasional requirement to work outside of normal business hours, consistent with other positions at this level.

TRAVEL

Some US and international travel will be required (< 25%).

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.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Target Pay Range:  $82,700.00 to $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.