Quality Assurance Specialist

Datwyler; Town of Middletown (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

Datwyler is seeking a QA professional to manage quality requirements for a GMP-regulated manufacturing environment. The role supports the site quality system and adheres to global group quality policies, ensuring compliant documentation and robust quality processes across operations.

The incumbent will lead investigations, CAPA, change control, and audit activities, collaborating with operations, supply chain, and engineering to balance quality with cost and efficiency. Fluent English required.

Qualifications

• Bachelor’s degree in science or engineering preferred.
• 3–5 years of QA experience in a regulated environment.
• Thorough knowledge of cGMP regulations and current industry practice.
• Knowledge of ISO 9001 and ISO 15378.
• Fluent in English (written and spoken).
• Experience in customer-facing roles desirable.

Responsibilities

• Ensure Quality Management System compliance with ISO 9001 and ISO 15378.
• Handle customer complaints, internal quality notifications, and CAPA processes.
• Lead investigations related to complaints and nonconformances.
• Support internal and external audits and follow up on audit actions.

Skills

Analytical skills

Technical writing

GMP knowledge

ISO knowledge

English fluency

Customer-facing experience

Education

Bachelor’s degree (preferred)

Job description

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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...

Summary / Objective

This position handles 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

• Supports 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.
• Supporst 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.
• Handles customer complaints, internal quality notifications, change control process, the CAPA process, and leads the investigations related to complaints and NCs. 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.
• Supports 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).

Additional Functions

• Ensures the continuity and the compliance of the site’s Quality Management System according to global and local standards (e.g. ISO 9001/15378, global group Quality procedures) and at acceptable cost.
• Provides interdepartmental assistance to ensure that controlled documents reflect current practice. Ensure proper document distribution and continually improve the flow of the documentation process.
• Coordinates customer complaints, including overseeing the investigation with the relevant departments in the site.
• Processes and evaluates nonconformances and CAPAs.
• Runs the local change control process.
• Supports for internal and external audit performance (customers, regulatory agencies and suppliers) and follow up of the outcome (action plan).
• Defines and implements quality related projects with the aim to significantly improve the Quality and/or compliance level.
• Partners with operations to support site objectives. Find a good balance between quality requirements, compliance and costs.
• Supports quality and continuous improvement activities as assigned by manager.

Requirements

• Bachelor’s Degree preferred. Science or engineering-related field a plus.
• 3-5 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.
• Strong analytical and technical writing skills
• Good knowledge of domain-specific legislation, relevant standards and procedures.
• Fluent in English, both verbal and written.
• 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.