Quality Controller in automotive sector focusing on inspections and rework of components at Vollmann Group. Ensuring quality standards and compliance with technical specifications at Crimmitschau site.
WS
Hybrid Manager, Quality Assurance – Integrated Systems
Posted yesterday
About the role
- Customer Quality Manager overseeing Quality Management Systems and supplier performance metrics. Ensuring customer quality issues are resolved effectively and compliance is maintained at West Pharmaceutical Services.
Responsibilities
- The primary responsibilities of the Customer Quality Manager, Integrated Systems, involve over-sight of the Quality Management System (QMS), Customer Quality issues, questions / concerns, Customer facing related items and audits as well as overseeing supplier performance metrics and support / drive supplier audits, out of specification (OOS) investigations.
- Lead and drive internal teams to resolve Out of Spec (OOS) quality issues and be the main point of contact for customers on these issues.
- Partners closely with internal stakeholders i.e Operations, Technical Customer Support, Sales, Labs, R&D, and Product Management to ensure that customer quality issues are resolved in a timely manner and the needs of the customer are being met.
- Maintaining and reporting metrics and trends to Senior Management and Extended Leadership Team (ELT) and implementing improvements on a continuous and pro-active basis.
- Generate, manage and oversee customer and supplier quality agreements.
- Ensuring compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities.
Requirements
- BA/BSE in a technical or related field plus 5 years of demonstrated experience in the administration of Quality Systems, or a combination of education and experience.
- Must have 5+ years’ work experience in Medical Device or Pharmaceutical Manufacturing Environment.
- A thorough working knowledge of quality systems such as ISO 15378 /ISO 13485 / 21 CFR Part 820 / EU GMP is essential.
- Accredited lead auditor against recognized quality standards in support of audits
- Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971.
- Experience of hosting regulatory audits from either the European or US authorities
- Must have excellent communication and written skills
- Must be able to work in a fast paced environment.
- Must be able to travel as required by the position.
- Must be able to organize and prioritize tasks, problem solve, must be detail orientated and self-motivated.
- Must be able to work independently on own projects while working concurrently with all departments.
Benefits
- Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
- Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
- Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
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