Quality Assurance Manager

Quality Assurance Manager × Apply for Job × × × Enter your email to apply

Date:

May 4, 2026

Location:

Middletown, DE, US, 19709

Company:

Datwyler 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... The Quality Assurance Manager supports and strengthens the site's Quality function by ensuring that all operations comply with GMP, regulatory requirements, internal quality standards, and customer expectations. Working closely with the Director of Quality, this role oversees day‑to‑day Quality Assurance (QA) activities depending on the organization's structure. The Quality Assurance Manager drives continuous improvement, maintains a strong quality culture, and ensures the consistent manufacture of safe, effective pharmaceutical products. Essential Functions Quality System Oversight Leads the Regulatory and External Customer Audits including preparation, execution and follow-up. Maintains and continuously improves the site's Quality Management System (QMS) in alignment with

ISO 9001, ISO

15378, and other applicable regulations. Oversees deviation management, CAPA, change control, complaints, and risk assessments, escalating critical issues to the Director of Quality. Ensures timely and compliant batch record review and product release processes. Compliance & Documentation Ensures all GMP documentation is accurate, complete, and maintained according to data integrity principles (ALCOA+). Reviews and approve SOPs, validation protocols/reports, and quality-related technical documents. Provides regular compliance updates and quality metrics to the Director of Quality. Monitors compliance trends and implement corrective actions where needed. Leadership & Team Management Manages and develops QA staff, providing coaching, training, and performance evaluations. Collaborates with the Director of Quality to set departmental goals, allocate resources, and align quality initiatives with site strategy. Fosters a culture of quality, accountability, and continuous improvement across the organization. Collaborates cross‑functionally with Production, Engineering, Supply Chain, and R&D. Continuous Improvement Leads quality improvement initiatives using tools such as Lean, Six Sigma, and root cause analysis. Identifies opportunities to streamline processes while maintaining compliance. Tracks and reports quality KPIs to senior leadership. Experience and Education Requirements Bachelor's Degree required. Science or engineering-related field a plus 5-7 years of relevant work experience, in a Q Manager/Engineer 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 International travel propensity required 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

Nearest Major Market:

Philadelphia × Apply for Job × × × Enter your email to apply