Quality Assurance Specialist

4 weeks ago

Middletown, United States Datwyler Full time

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...

Summary/Objective

This position manages 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 focussed on the operations of a state-of-the-art, clean, pharma packaging manufacturing environment.

Essential Functions / Four Most Important Tasks

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  1. 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.
  2. Support the Quality Management System: ensure the compliant status of the QMA with the requirements of ISO 9001 and ISO 15378.  Provide interdepartmental assistance to ensure that controlled documents reflect current practice.  Ensure proper document distribution and continually improve the flow of the documentation process. 
  3. Manage customer complaints and internal quality notifications.  Lead investigations related to complaints and QN’s.  Manage the change control process.  Manage the CAPA process.  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. 
  4. 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). 
Responsibilities
  • Duly follows organizational and work specific instructions, attends applicable trainings and meetings.
  • Fulfils tasks efficiently and in due course. Meets productivity standards (where defined). Can organize and perform work effectively. Sets priorities correctly.
  • Abides by safety regulations at all times. Promotes safety standards at work place and in the team. Identifies potential safety risks and reports them actively to line manager.
  • Demonstrates initiative to exceed a common performance. Flexibly adopts changes in tasks, work place, or team. Works reliably, keeps agreements. Assumes responsibility for tasks entrusted.
  • Is open, respectful, and helpful. Constructively contributes with own skills to problem solving in team. Shares and accepts information and knowledge.
  • Ensure the continuity and the compliance of the site’s Quality Management System according to global and local standards (e.g. ISO 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.
  • Manage customer complaints, including coordinating the investigation with the relevant departments in the site.
  • Manage the local change control process.
  • Support for internal and external audit performance (customers, regulatory agencies and suppliers) and follow up of the outcome (action plan).
  • 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
  • Participates in department and inter-department meetings. Suggests improvements and works alone or with others to implement improvements, as assigned.
  • Supporting continuous improvement activities and initiatives
  • Trains trainees as requested.
Required Education and Experience
  • Bachelor’s Degree required. Science or engineering-related field a plus.
  • 4-6 years of relevant work experience in a QA role.
  • Experience with classified area’s is preferred.
  • 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.

 

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.

www.datwyler.com

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