Sr. Supplier Quality Engineer

Position Summary

The Senior Supplier Quality Engineer plays a critical role in ensuring the reliability of materials used in sterile barrier systems that protect life-saving medical devices.  The role supports the qualification, development and performance management of suppliers providing critical raw materials for the creation of sterile barrier packaging systems, as part of Oliver’s Global Supplier Quality Team.

The position utilizes technical expertise in flexible packaging materials and manufacturing processes to ensure that supplied materials consistently meet Oliver specifications, regulatory requirements, and customer expectations.   The position works cross-functionally with Procurement, R&D, Engineering, Manufacturing and Technical Service functions to qualify new suppliers, support new material development, manage supplier changes, and drive continuous improvement of the quality of supplied materials.   The role works closely and effectively with Oliver’s global suppliers to ensure robust and validated processes, quality systems and continuous improvement programs are in place.

The position is ideally based at or near one of Oliver’s manufacturing facilities in the USA or Europe, or in a hybrid or on-site working model.

Primary Responsibilities / Essential Functions

Supplier Qualification and Development

• Lead the technical evaluation, qualification, and ongoing performance management of suppliers providing flexible packaging materials and sterile barrier components.
• Conduct supplier audits, technical process assessments, and capability evaluations to ensure supplier manufacturing processes meet Oliver quality and regulatory requirements.
• Provide technical leadership in supplier development initiatives to improve process capability, quality performance, and regulatory compliance.

Supplier Process Validation

• Provide technical leadership and oversight for validation activities at suppliers, including IQ/OQ/PQ, process validation, and test method validation related to flexible packaging materials and manufacturing processes.
• Review and approve supplier validation protocols, reports, and supporting documentation.
• Support supplier implementation of Control Plans, PFMEAs, and process monitoring systems.

Flexible Packaging Material and Manufacturing Process Expertise

• Serve as a subject matter expert in flexible packaging materials/structures and manufacturing technologies for global Quality teams.
• Work closely with R&D subject matter experts to provide Quality guidance during new product development and customer-specific product development projects which depend on supplied flexible packaging materials.

Change Management and Risk Assessment

• Evaluate the technical impact of supplier or raw material changes on Oliver products and customer applications.
• Participate in cross-functional change control and other material change related risk assessment and decision-making bodies.
• Lead or support risk assessments including PFMEA and risk-based decision making for supplier and material changes.
• Work closely with suppliers to ensure changes are implemented correctly and on time.

Quality and Compliance

• Lead investigations related to supplier quality issues, including root cause analysis, CAPA investigations, and corrective action verification.
• Ensure supplier processes and materials comply with applicable medical device regulatory requirements and industry standards, including ISO 13485 and ISO 11607.

Cross-Functional Collaboration

• Partner with Procurement, R&D, Engineering, Manufacturing and Technical Service functions to support supplier selection, material qualification, and supplier performance improvement.
• Proactively communicate supplier performance risks, material issues, and technical findings to internal stakeholders.

Field Support and Supplier Engagement

• Travel to global suppliers on location to build constructive relationships and oversee supplier activities related to audits, technical reviews, validations, trial runs, and improvement initiatives as necessary.

Qualifications

Oliver welcomes candidates with either of the following backgrounds:

• Deep technical expertise in flexible packaging materials and manufacturing processes, with an interest in developing supplier quality and regulatory expertise
• Supplier quality or packaging quality leadership experience within medical device or pharmaceutical packaging environments, with strong understanding of flexible packaging materials

Education and/or Experience:

• Bachelor’s degree in Packaging Engineering, Materials Science, Chemical Engineering, Mechanical Engineering, Printing Technology, or related technical field
• Minimum 5 years’ experience in the flexible packaging industry or related industries with a strong flexible packaging focus, preferably in quality, product development or engineering-related roles.
• Experience working with global supplier networks in the flexible packaging industry
• Proven experience and expertise in flexible packaging materials (one or more of coextruded films, multilayer films & laminates, coated materials and medical grade nonwovens) and their manufacturing processes (one of more of blown/cast film extrusion, extrusion/adhesive lamination, coating, printing, slitting and converting) are strongly preferred.
• Experience in common packaging test methods such as seal integrity testing, leak testing, burst testing and transport testing preferred.
• Experience leading supplier process validation and qualification activities preferred.
• Experience in medical device packaging or pharmaceutical packaging environments preferred.
• Knowledge of medical device packaging standards including ISO 13485, ISO 11607 preferred.
• Knowledge of common Quality & statistical tools such as pFMEA, DOE, Gauge R&R, Statistical Process Control (SPC) preferred.
• ASQ certification (CQE, CQA, or similar) preferred.

Interpersonal Skills:

• Ability to read, analyze and interpret technical periodicals, professional journals, technical procedures and/or governmental regulations
• Ability to write in a clear and concise manner
• Ability to speak effectively, present information and respond to questions in a clear and concise manner.
• Ability to influence cross-functional teams and supplier organizations in a constructive manner

Skills and Competencies

• Strong technical leadership and supplier engagement skills.
• Ability to influence and collaborate across global teams and supplier organizations.
• Excellent analytical, problem-solving, and risk assessment skills.
• Strong written and verbal communication skills with the ability to present complex technical information clearly.
• Strong negotiation and supplier relationship management capabilities.

Working Conditions

This position works in an on-site or hybrid working model within a combination of laboratory, manufacturing, and office environments, includes extensive travel to supplier manufacturing facilities.

Special Requirements

• Ability to travel (US and internationally)
• Ability to work evenings and/or weekends