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Quality Assurance Specialist

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Date: Jan 9, 2022

Location: Middletown, DE, US

Company: Datwyler

The Sealing Solutions division is a leading supplier of custom sealing solutions to global industry segments, such as the health care, automotive, consumer goods, oil and gas, general industries, as well as civil engineering. We are always looking for talented, highly qualified employees at all levels of our organization. Datwyler offers the opportunity to join exciting industries and to be part of a highly esteemed brand. From production staff to client advisors, from technology experts to design engineers, from China to Mexico: at Datwyler, our employees will experience diversity in a way that only an international company can provide. We focus on helping talents reach their full potential – professionally and personally. Our working environment is shaped by our values and beliefs: we are entrepreneurs, we bring value to our customers, we excel in what we do and we have respect for others. With more than 20 global operating sites and more than 7,000 employees, Datwyler Sealing Solutions generates an annual revenue of approximately CHF 900 million. Based on a strategic decision, we are looking for 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 focused on the operations of a state-of-the-art, clean, pharma packaging manufacturing environment.

Essential Functions

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.

Your Profile

  • Bachelor’s Degree required. Science or engineering-related field a plus.
  • 2-5 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.

 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

The QA position requires moving about as much as 30% of the workday in and throughout the office and plant; and the occasional lifting of up to 15 pounds. This position can require occasional squatting, stooping, bending or crouching. Use of computer involves some repetitive motion. Business needs require that the employee in this position work an established 40-hour workweek and on occasion work additional hours outside of the standard schedule.

Our Offer to you

  • Generous health benefits package with eligibility on first day of employment
  • 401(k) retirement program
  • Dental Insurance
  • Vision Insurance
  • Disability Insurance
  • Employee Assistance Program
  • Life Insurance
  • Paid time off vacation
  • Paid time off sick

 

We Offer a Diverse and Global Working Environment
As a globally operating company, Datwyler offers a broad spectrum of job profiles and career opportunities. We offer ambitious individuals who approach their task with dedication and enthusiasm the right environment to excel and grow. This gives every employee the opportunity to influence the way we work. At Datwyler, we enable our employees to bring their talent to a global context and grow it steadily over time. Our employees are therefore at the very heart of Datwyler – we interact with respect, trust and loyalty. Mutual consideration and appreciation are key.
www.datwyler.com
 


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