Requisition ID: 32701
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.
JOB TITLE: Quality Engineer Level 3
JOB SUMMARY
The Quality Engineer 3 is responsible for factory support and the execution of quality initiatives at the Littleton site. This role operates in a fast-paced environment and requires creative thinking to support factory thruput while maintaining a high level of compliance and quality. The role serves as a change agent for driving a culture of discipline, transparency, and accountability and concentrates on continuous improvement with a zero-defect mindset. Working at the level of an Engineer 3, this role requires judgment, evaluation, selection, and adaptation/modification of standard techniques for problem solving and quality improvement.
ESSENTIAL DUTIES
- Demonstrate leadership and initiative within the Quality team
- Leads cross-functional investigations in response to customer complaint, nonconformance, and CAPA scenarios
- Support timely completion of investigations and decision-making to prevent outflow of nonconforming product
- Gather and monitor data that aids in the prevention of reduction of defect opportunities
- Collaborate cross-functionally to maintain factory and quality initiatives simultaneously
- Appropriately compile data and results and present to cross-functional teams in an effective manner
- Identify project opportunities that achieve strategic business goals and improve efficiency and compliance of QMS
- Promote and demonstrate effective communication to achieve "cross pollination" in all areas, at all levels
OTHER DUTIES AND RESPONSIBILITIES
- Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).
- May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
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
- Bachelor of Science Degree in Engineering, preferred
Experience
- Minimum 4 years experience
- Two years of GMP manufacturing experience required
- Experience with medical device manufacturing validation experience preferred
Skills
- Requires demonstrated skills in technical innovation, technical leadership, and mechanical engineering
- Strong technical problem solving skills. Ability to define problems, collect data, establish facts and draw valid conclusions
- Stronginteractive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support team as requested
- Positively resolves workgroup conflict
- Understanding of and adherence to GMP practices and FDA regulations
- Demonstrated ability to communicate effectively both verbally and in writing
- Knowledge and use of relevant software applications (Minitab) and skills to use them effectively
- Ability to effectively present information and respond to questions from groups of managers and technical experts. Engaging presentation skills to large audiences (remote and in person)
- Ability to apply statistical methods found in DMAIC problem solving projects
- Understanding of advanced Six Sigma and statistical process control concepts, including control charts, variation, cause and effect relationships, hypothesis testing, DOE, Pareto principle, FMEA, MSA, and process capability.
- Certification as a Black Belt, or willingness to become certified
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
Competencies
- Analytical - Synthesizes complex or diverse information; collects and researches data; designs workflows and procedures.
- Process Design - Translates concepts and information into images; uses feedback to modify process designs; applies Lean process design principles; demonstrates attention to detail.
- Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations.
- Project Management - Develops project plans; coordinates projects; communicates changes and progress.
- Technical Skills - Strives to continuously build knowledge and skills.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
- Written Communication - Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively.
- Visionary Leadership - Displays passion and optimism; inspires respect and trust; mobilizes others to fulfill the vision; provides vision and inspiration to peers and subordinates.
- Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Business Acumen - Understands business implications of decisions; displays orientation to profitability; aligns work with strategic goals.
PHYSICAL REQUIREMENTS
General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
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.
Additional Physical Requirements
Requires travel based on business needs
Target Pay Range: $107,000.00to$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.