Engineer 3 - Global Supplier Quality

Requisition ID: 35467

At Terumo Blood and Cell Technologies, our 8,000+ global associates are 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.

JOB TITLE: Engineer Level 3

JOB SUMMARY

Terumo BCT is currently seeking a qualified candidate for the position of a Global Supplier Quality Engineer 3, which is responsible for improving supplier performance. Working with suppliers to improve process reliability, repeatability, controls and resolution of quality issues. Must be proficient in injection molding processing and tooling, process controls, validation and verification, test method validation, supplier auditing, supplier management, CAPA investigations, project management and application of pharmaceutical manufacturing processes, cGMP requirements, and quality system regulations.

Applies independent judgment to evaluate and adapt engineering methods, procedures, and standards. Uses broad knowledge of the specialty area and related disciplines while developing engineering expertise and understanding of company practices and policies.

ESSENTIAL DUTIES

• Functions as a member of the Global Supplier Sustaining Engineering Team working cross-functionally and proactively on supplier quality and management activities. These activities include:
  • Supplier Development and Process Improvement (predominantly EMEA suppliers)
  • Injection molding processing/tooling troubleshooting
  • Supplier Auditing and Performance monitoring
  • Component, tooling, and process validations / verification with technical reports
  • Test Method Validations and Gage Correlation
  • Project management of supplier quality initiatives.
  • Supplier selection, evaluations, and qualification.
  • Supplier Corrective Action Requests (SCAR’s) management
• Lead qualification, approval, and ongoing management of API suppliers, contract manufacturers, and critical raw material suppliers in accordance with cGMP requirements and company quality standards.
• Conduct risk-based supplier audits, including on-site, remote, and routine surveillance audits, to assess compliance with FDA, ICH, and applicable global regulatory requirements.
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Perform independent evaluation, selection, and application in making adaptations and modifications to projects.
• Review and approve supplier qualification documentation, including quality agreements, audit reports, GMP certifications, regulatory inspection histories, technical questionnaires, and supplier risk assessments.
• Monitor supplier quality performance through key performance indicators (KPIs), supplier scorecards, quality trends, defect rates, audit observations, and delivery performance.
• Lead investigations related to supplier quality issues, nonconforming materials, deviations, complaints, and out-of-specification (OOS) events impacting API quality.
• Issue, manage, and verify Supplier Corrective and Preventive Action Requests (SCARs), ensuring timely implementation and effectiveness of corrective actions.
• Assess and approve supplier-initiated changes, including manufacturing process changes, test method changes, equipment modifications, raw material changes, site transfers, and specification revisions through established change control processes.
• Ensure compliance with Quality Agreements and establish effective communication channels with suppliers regarding quality concerns, investigations, and regulatory commitments
• Ensure compliance with FDA 21 CFR Parts 210/211, ICH Q7, ICH Q9, ICH Q10, EU GMP requirements, and company quality policies governing API manufacturing and supplier management
• 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, Pharma or regulatory requirements as necessary.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Advises team members advise proactively on technical ideas and promotes skill development of teamwork.
• 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).
• 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

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 of relevant experience.
• Two years of GMP manufacturing experience in a regulated industry or similar field.
• Pharma operations or quality experience preferred

Skills

• Experience working with, or strong knowledge of, Active Pharmaceutical Ingredients (APIs) in a pharmaceutical, biotechnology, or medical device manufacturing environment is required. Must possess working knowledge of pharmaceutical manufacturing regulations and quality systems, including FDA 21 CFR Parts 210/211, ICH Q9 and Q10, EU GMP requirements, supplier qualification and auditing, quality risk management, CAPA systems, change control, data integrity principles, and management of supplier quality programs.
• 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.
• Continuous improvement mindset, e.g. LEAN, Six Sigma
• Project management and coordination with cross-functional team members
• Understanding of GD&T, Gage R&R, and Correlation studies
• Qualified Lead Auditor (ISO13485)
• Understanding of and adherence to GMP practices, Pharma 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.

-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 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 accommodation may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

May require up to 30% travel based on business needs.

Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India’s largest blood bag manufacturer, we provide a comprehensive range of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad. Our high-quality products touch the lives of patients in over 80 countries across the world.

True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture. Firmly rooted in core values collectively termed as the ‘Associate Spirit’, our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.