Quality Assurance Specialist

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

POSITION SUMMARY:

This position handles the quality requirements and standards for manufacturing products in a GMP-regulated environment. Being a hands-on person, the incumbent of this position will support the site quality system and procedures in alignment with the global group quality policies and applicable industry standards.

The responsibilities will be focused on the operations of a state-of-the-art, clean, pharma packaging manufacturing environment.

ESSENTIAL FUNCTIONS:

• Support the site in order to guarantee continuity of Quality systems and activities according to global and local standards and at acceptable cost. Partnering with operations to support site objectives. Find global balance between quality requirements, compliance and costs.
• Manage and maintain the Quality Management System: ensure the compliant status of the QMS with the requirements of ISO 9001. Provide interdepartmental assistance to ensure that controlled documents reflect current practice. Ensure proper document distribution and continually improve the flow of the documentation process.
• Supports customer complaints, internal quality notifications, change control process, the CAPA process, and supports the investigations related to complaints and Nonconformances. Define and implement quality related projects with the aim to significantly improve the Quality and or compliance level. Liaise with relevant groups on site (e.g. operations, supply chain, engineering, etc.) and cooperate to come to a timely resolution of the mentioned QA processes.
• Support for internal and external audit performance (customers, regulatory agencies, ISO and suppliers) and follow up of the outcome (e.g. audit report, corrective actions, replies to external auditors and customers).
  • Manages/conducts training of Internal Auditors for the site (annually)
  • Completes preparation for external audits (including ISO certification)
  • Supports preparation for EHS certification (140001 and 450001)
• Ensure the continuity and the compliance of the site's Quality Management System according to global and local standards (e.g. ISO 9001/15378, global group Quality procedures) and at acceptable cost.
• Provide interdepartmental assistance to ensure that controlled documents reflect current practice. Ensure proper document distribution and continually improve the flow of the documentation process.
• Support customer complaints, including support of the investigation with the relevant departments in the site.
• Support the local change control process.
• Define and implement quality related projects with the aim to significantly improve the Quality and/or compliance level.
• Partnering with operations to support site objectives. Find a good balance between quality requirements, compliance and costs

EDUCATION AND EXPERIENCE:

• Bachelor's/Master's Degree preferred.
• 3-5 years of relevant work experience in a QA role.
• Experience with classified areas is preferred.

SKILLS AND ABILITIES:

• Thorough knowledge of cGMP regulations and current industry practice.
• Knowledge of ISO 9001 and ISO 15378.
• Good knowledge of domain-specific legislation, relevant standards and procedures.
• Fluent in English, both verbal and written.
• Experience in customer-facing role desirable.

PHYSICAL REQUIREMENT:

The conditions herein are representative of those that must be met by an employee to successfully perform the essentials of this job, and are subject to modification at the company's discretion, without notice. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential job functions, provided it does not create an undue hardship on the Company, in accordance with applicable law.

Work conditions are those that are present in normal manufacturing environment.

The work of this position requires sitting in an office environment in front of a computer screen as much as 80% of the workday. Occasionally using force to lift, push or pull between 5 and 15 pounds. This position also requires some standing, pulling (e.g., files, boxes, or binders from shelves, filing cabinet or carts), fingering (computer keyboard), grasping (computer mouse, talking, and hearing.

Use of computer involves some repetitive…