Job title: Supplier Quality Engineer 3
Company: Terumo BCT
Job description: Requisition ID: 26903
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.
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.
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. Consider joining our team and unlock your potential.
Supplier Engineer Level 3
Terumo BCT is currently seeking qualified candidates for the position of Supplier Engineer III, which is responsible for working with Suppliers and Contract Manufacturing Organizations (CMO) to improving process reliability, repeatability, controls and resolution of quality issues. Supplier Engineers must be proficient at process controls, project management, process validation and verification, process improvement, supplier auditing, supplier management, and CAPA investigations. Position will have a focus process development, Quality plans, tool design and equipment requirements related to injection molding and die casting.
Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.
- Responsible for process improvements related to New Product Introduction (NPI) and Contract Manuacturing
- Supports relationship with key suppliers, including CMO(s) and acts as Point of Contact for resolution of technical issues and concerns
- Functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities. These activities include:
- Tool Design and Process Development that drives zero defect approach to quality
- New Product Introduction (NPI)
- Area of concentration includes injection molding, blow molding and high volume automation.
- Component, tooling, and process validations / verification
- Project management of supplier quality initiatives.
- Supplier selection, evaluations, and audits
- Corrective and Preventative Action (CAPA)
- Perform independent evaluation, selection, and application in making adaptations and modifications to projects.
- Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
- Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
- Implements and understands FDA or regulatory requirements as necessary.
- Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
- Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
- Advises team members pro-actively on technical ideas and promotes skill development of team work.
- Interacts with peers across projects to secure resources and commitments.
- Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
- Follows technical specification requirements and provides feedback on various technical processes and procedures.
- Presents effectively complex technical information/analysis, and responds to questions from technical staff members and management.
- Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
OTHER DUTIES AND RESPONSIBILITIES
- Work direction responsibility may include technicians and junior engineers.
- May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
MINIMUM QUALIFICATION REQUIREMENTS
- 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. Mechanical, Industrial, or Biomedical preferred.
- Masters of Science Degree in Engineering, optional.
- Minimum 4 years experience.
- Two years of GMP manufacturing experience required.
- Minimum 4 years of injection molding, die casting, or device manufacturing at contract manufacturers experience required
- Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.
- Strong interactive 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 for subordinates, junior engineers, technicians, and management.
- Strong technical problem solving skills.
- Mechanical and electronic ability aptitude to assist with equipment trouble-shooting.
- Understanding of and adherence to GMP practices and FDA regulations.
- Knowledge and ability to implement FDA or regulatory requirements as necessary.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
An equivalent competency level acquired through a variation of these qualifications may be considered.
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.
- 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.
Location: Lakewood, CO
Job date: Thu, 05 Nov 2020 01:06:52 GMT