Quality Technician

BD; Castilla y León; On-site; EUR 24,000 - 36,000; Full time

Job summary

Waters is seeking a Quality Technician in Salamanca to support the design, manufacture, and release of clinical and research products that meet specifications. The role contributes to product safety, QMS maintenance, and regulatory compliance in a regulated testing environment.

The position reports to the Quality Manager, performing environmental monitoring, validation, disposition, CAPA, complaints, and quality documentation to ensure quality and compliance. Fluent English is required.

Qualifications

• Bachelor's degree in Life Sciences or equivalent.
• Minimum 1 year in a regulated industry or equivalent.
• Knowledge of ISO 13485 and/or ISO 9001 standards.
• Knowledge of GMP requirements.
• High level of English.

Responsibilities

• Ensure Quality Notifications are created, investigated, and closed per SOPs.
• Identify quality events and support investigations; report to Quality Manager.
• Support investigations, complaints, CAPAs, changes, and quality records.
• Monitor, document, and analyze Quality Metrics.
• Batch record QA review and data gathering for management reviews.
• Draft and update SOPs, reports, and quality documents.
• Support audits by regulatory bodies, Notified Bodies, and customers.

Skills

English proficiency

Education

Bachelor's degree in Life Sciences

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

The Quality Technician reports to the Quality Manager in Salamanca. This position participates in activities supporting the design, manufacture, and release of clinical and research products that meet established specifications. These activities to be supported include: environmental monitoring, validation, material disposition, in-process product disposition, finished goods disposition, data collection/trend analysis, quality auditing, Quality/Compliance Training, CAPA, complaint processing & investigation, quality record retention, quality documentation and change control process.

The role contributes to ensure product safety, product quality, QMS maintenance, the compliance with and application of quality standards, regulations and customer expectations.

Responsibilities

• Assure that Quality Notifications (QN) are created, investigated, completed and closed in accordance to the established Standard Operating Procedures.
• Identify quality events and support investigations. Report quality issues to Quality Manager.
• Support other associates or departments in the proper follow-up, documentation and completion of complaints, changes, CAPAs, corrections and other quality records.
• Monitor, document and analyze Quality Metrics.
• Batch record QA review.
• Gather information for the Quality Management Reviews, for the preparation of reports and other department activities.
• Draft and update local SOPs or working instructions, analysis reports, plans and other quality documents.
• Support the Quality department in audits (external, internal and customer) and other investigations from regulatory agencies, Notifies Bodies, and customers.
• Act as a role model for Quality by the daily representation of all quality aspects and modeling and emphasizing quality in the workplace.
• Keep abreast of the basic requirements for compliance in own area of work and comply with those requirements. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.
• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

Education and experience

• Requires a bachelor's degree (preferred Life Sciences)
• A minimum of 1 year relevant technical experience in a regulated industry or a combination of equivalent education and experience.
• Knowledge of ISO 13485 and/or ISO 9001 standards is required
• Knowledge of Good Manufacturing Practices (GMP) is expected
• High level of English

Salary for this role 24000€ + benefits

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

ESP Salamanca

Salary Range Information

€23,700.00 - €36,150.00 EUR Annual