Quality Specialist

Job Description

KEY Responsibilities:

• Work as part of Vilnius site Quality team to support the function including auditing of internal supplier performance and systems & processes. 
• Maintain internal supplier approval status through review and approval of new requests and change requests as per applicable standard or requirements. 
• Lead and own the execution of objectives for the control of internal suppliers, in alignment with goals of the company and objectives.
• Ensure alignment between internal suppliers and related quality requirements and specifications.
• Develop, implement, and maintain appropriate metrics to assess internal supplier performance.  Provide timely and accurate communication to team on internal supplier performance metrics.
• Lead meetings related to internal supplier performance monitoring, issue resolution, strategy definition for specific suppliers. 
• Support processes for new material qualification, end of life materials/components, product development, internal supplier requests for material changes and sustaining engineering. 
• Drive problem solving and root cause analysis activities with internal suppliers to eliminate recurrence of non‐conformances.
• Collaborate with other departments effectively to define actions and priorities for internal supplier related quality issues. 
• Support the Material Review Board meetings and other critical decision-making meetings as required to define internal suppliers' responsibilities and effectiveness. 
• Align with Purchasing to report internal supplier performance while monitoring ratings and uncooperative internal suppliers.
• Develop relationships with critical internal suppliers to support the business.
• Work with relevant business Unit leaders to facilitate integration of new internal suppliers.
• Review and assess internal supplier notification of change and communicate accordingly.
• Ensure issues such as delays in audits, delays in raw material non-conformity investigation etc. are prioritized appropriately and resolved effectively.

Requirements for qualification / Education / Experience:

Minimum Requirements/Qualifications:

• Bachelor’s degree (or higher) in engineering, science or operations.
• Strong English language communication skills both written and verbal.
• Project planning and working knowledge of Excel, Word, Access, and quality management software.
• High ethical standards to support a professional business code of conduct.

Other Qualifications:

• Quality auditing certification (ISO9001, ISO13485) preferred.
• Demonstrated experience on requirements of Quality Management System (ISO9001, ISO13485, CFR Part 820) and Good Manufacturing Practice (GMP).
• Knowledge of Quality Systems (ISO9001, ISO13485, CFR Part 820), IVD/medical device/Pharma manufacturing and regulatory requirements over a number of years.
• Well-versed in the development and execution of quality management systems. 
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment. 
• Leadership skills: Proven ability to influence others, lead significant change and negotiate for win/win outcomes. 
• Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.

The annual minimum and maximum salary range is €21,800.00 to €32,675.00, respectively.

This translates to a monthly salary range of approximately €1,816.67 to €2,722.92 before taxes.

Compensation and Benefits

The salary range estimated for this position based in Lithuania is €23,800.00–€35,650.00.