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Head of Plant Quality Management

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Date: Jun 8, 2021

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…

Head of Plant Quality Management Summary / Objective

The position is situated in our facility at Middletown, Delaware. The Head of Quality Management is the overall Quality responsible of the site. The incumbent of this position applies and maintains (customer) quality requirements and standards for manufacturing products in a GMP environment that values continuous improvement.  The position requires a hands-on person who can maintain site quality systems and procedures in alignment with the global quality policies and applicable standards.

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

Essential Functions

  • Responsible for the site Quality team (QA + QC). Manage personnel matters in order to guarantee continuity of Quality systems and activities according to global and local standards and at acceptable cost.
  • Manage the Quality Management System: maintain and continuously improve the QMS and ensure certification according to the requirements of ISO 9001 and ISO 15378 .
  • Develop the Quality targets for the site together with the local management team and aligned with overall site targets and global objectives and key results.
  • Coordinate internal and external (customers, regulatory, ISO and suppliers) audits. Manage the outcome of such audits.
  • Take final responsibility for Quality related matters with customers such as review and approval of Quality agreements and management of Customer quality complaints. Cooperate with the Quality Key Account Manager for selected customers.
  • Review and approval of deviations, change control requests, validation documents and specifications.
  • Support the Quality Control team in order to ensure proper testing for incoming materials, in process controls and final release of finished goods.
  • Quality projects: Define and implement projects with the aim to significantly improve the Quality / compliance level.
  • Partnering with operations to support site objectives. Find a good balance between quality requirements, compliance and costs.
  • Contribute to global Quality initiatives in order to define the global Quality standards.

Physical Requirements

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.  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 office and manufacturing environment.

 

The work of this position requires sitting as much as 80% of the workday, and using force to lift, push or pull between 25 and 30 pounds. The incumbent of this position will frequently go up and down stairs between office, labs and production areas. Occasionally, the work requires climbing (portable ladders to get samples), balancing (when carrying boxes), and reaching (in Samples area of Warehouse).  This position also requires some standing, pulling (e.g., boxes from shelves or carts), fingering (computer keyboard), grasping (e.g., computer mouse), talking, and hearing.  Use of computer involves some repetitive motion. 

 

Your Profile

  • Bachelor’s Degree required. Science or engineering-related field a plus
  • 5-7 years of relevant work experience, in a Q Manager role
  • Thorough knowledge of cGMP regulations and current industry practice
  • Knowledge of ISO 9001 and ISO 15378
  • Good knowledge of domain-specific legislation, standards rules and procedures
  • Fluent in English, both verbal and written
  • Experience in customer-facing role desirable

 

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
 


Nearest Major Market: Philadelphia