Manager, Engineering - Supplier Quality

Requisition ID: 30881
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 Quality Engineering Manager will focus on the management of the External Manufacturing SQE team with function including the daily management, maintenance, and monitoring of the relevant activities of all team members. This involves leading an engineering team that works collaboratively with Suppliers, Product Development, Procurement, and Quality to ensure compliant materials. Responsibilities include oversight of extensive portfolio of CMO and distributed product suppliers, implementation of quality improvement strategies, and alignment of global supplier management requirements. Works collaboratively developing objectives, plans, and global strategies to ensure effective achievement of business goals and objectives.
ESSENTIAL DUTIES
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.
Manages quality and technical performance of External Manufacturing Suppliers and Distributed Products.
Drives Holistic Quality strategy at supplier so ensure continuous review and improvement of product quality.
Manages improvements to product quality through strategic sourcing activities, supplier process improvements, and supplier corrective actions.
Ensure all SQE members have sufficient training and knowledge to execute their tasks
Actively participates in the annual budgeting process and may be responsible for managing an operation within budgetary guidelines.
Develop and maintain KPIs for Suppliers and Team to ensure periodic oversight of Supplier Performance.
Creates, maintains, and analyzes data for functional area.
Enhances, recommends, and implements internal policies and procedures including those that relate to our regulated environment.
Identifies a wide range of trends or problems, including the most complex, and solves or directs their solution and or interprets and recommends actions.
Identifies, recommends, and implements means to continuously improve the quality of service.
Oversees and provides leadership to ensure incoming and in-process quality inspection activities achieve the targets and continuously improve and adapt to the need of business.
Prepares and gives effective presentations on the performance and processes of the group.
Collaborates with engineers or scientists in the design, development, and building of test fixtures, test protocols, procedures, monitoring strategies, or inspection results commensurate with experience level.
Performs technical, administrative, and logistical responsibilities in identifying work area needs.
Provides leadership in ensuring all team members are included in overall conphrehensive training program which addresses the current needs and the future needs of team members.
Ensure timely execution of Supplier Quality Engineering tasks reflective of business strategic needs
Participate in strategic planning and execution within Quality department.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in Engineering, Science or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Bachelor’s of Science degree or may have a Master of Science degree, in Engineering, preferred.
Preferred education or equivalent experience in the field of Industrial, Mechanical, or Biomedical Engineering.
Experience
Minimum 7 years experience in pharmaceutical, medical or related field in the realm of supplier management
Two years of GMP manufacturing experience required.
Skills
Must have solid knowledge of Supplier Management regulatory requirements (FDA 21CFR820, ISO 13485) and ability to develop and maintain compliant, effective, and efficient processes.
Strong leadership capabilities to ensure continuous guidance, coaching, and directing teams to successs in their tasks and professional development
Proven ability to drive supplier performance improvements through direct communication and influence.
Strong project management, problem-solving, resource management skills
Demonstrated skills in developing, coaching, and training others in an organizational setting.
Excellent in collaboration methodologies in working with cross-functional groups.
In-depth knowledge of ISO 13485, 21CFR820, and Supplier Quality Management requirements.
Demonstrated ability to interact with regulatory agencies.
Knowledge and experience in one or more of the following areas:
Metrology Engineering disciplines or technical training.
Data analysis methodologies.
Manufacturing Processes: statistics, math, or related engineering sciences.
Demonstrated ownership for customer service orientation and approach to problem solving.
Able to perform the highest level of complex testing, inspects raw materials using standard or custom tools, and conducts and reports quality assurance trends and metrics.
Knowledge and use of relevant PC software applications and skills to use them effectively.
Demonstrated ability to communicate effectively both verbally and in writing (English and Vietnamese)
Extensive experience in working with suppliers of materials and services

• Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.
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 50lbs.
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: $121,200.00 to $151,500.00 - 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: 15.0%
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. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
Nearest Major Market: Denver
Job Segment: Biomedical Engineering, Testing, Quality Engineer, Pharmaceutical, Engineer, Engineering, Technology, Science