Location: Middletown, DE, US, 19709; Pennsauken, NJ, US, 8110
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
The Head of Quality Management USA is the overall Quality responsible of our Healthcare Solutions sites in Middletown, DE and Pennsauken, NJ. Within those facilities, Datwyler produces rubber and aluminum parenteral drug packaging components.
The position will report into the Head of Global Quality Healthcare Solutions.
Responsibilities
- Lead and manage the Quality department at our Healthcare sites in Middletown, DE and Pennsauken, NJ in order to guarantee continuity of the quality processes and activities according to global and local standards and at acceptable cost.
- Manage the Quality Management Systems at both sites: maintain the QMS and ensure continued certification according to the requirements of ISO 9001 and ISO 15378.
- Collaborate with management and senior staff at the sites to achieve the sites' objectives and to increase quality awareness.
- Coordinate and participate in internal and external (customers, regulatory, ISO, and suppliers) audits. Manage the results 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.
- Review and approval of deviations, change control requests, validation documents, and specifications.
- Support the Quality Control teams in order to ensure proper testing for incoming materials, in-process controls, and final release of finished goods.
- Define and implement projects with the aim to significantly improve the Quality/compliance level.
- Contribute to global Quality initiatives in order to define or optimize the global Quality standards.
Your Profile
- Minimum 5 years of proven experience in a Quality leadership position within a cGMP regulated environment.
- Bachelor’s Degree required, preferably in a science or engineering-related field.
- Thorough knowledge of cGMP regulations, ISO9001, ISO15378, and current industry practices.
- Good knowledge of domain-specific legislation, standards rules, and procedures.
- Fluent in English, both verbal and written.
Our Offer to you
Our Employees Are Our Most Valuable Asset #FOR YOU
That’s why at Datwyler Sealing Solutions we are committed to a comprehensive employee benefit program that helps our employees stay healthy, feel secure, and maintain a work/life balance.
Stay Healthy
- Medical Benefits – eligible on 1st day of employment
Feeling Secure
- Company paid Term Life and Accidental Death & Dismemberment
- Option to purchase additional Life insurance
- Short / Long Term Disability
Work/Life Balance
- Paid Time off (vacation)
- Paid Time off (sick)
- Twelve (12) paid holidays
- Flexible Spending Accounts
- Employee Assistance Program
Be yourself at Datwyler
We are convinced that people make the difference. At Datwyler, you'll 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 your creativity and all your ideas.