Dätwyler
Head of Quality Management
Dätwyler, Middletown, Delaware, United States, 19709
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 the 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.
Experience in a customer-facing role desirable.
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
Dental Benefits
Vision Benefits
Feeling Secure
401(k) retirement program
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 holiday
Flexible Spending Accounts
Employee Assistance Program
#J-18808-Ljbffr
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 the 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.
Experience in a customer-facing role desirable.
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
Dental Benefits
Vision Benefits
Feeling Secure
401(k) retirement program
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 holiday
Flexible Spending Accounts
Employee Assistance Program
#J-18808-Ljbffr