Quality Assurance Specialist at BVI Medical

B

Quality Assurance Specialist

BVI Medical

Brill, South Holland, Netherlands

On-Site

Intermediate

posted 39 days ago

View company profile

Vacancy Summary

As a Quality Assurance Specialist, you will enhance our Quality Management System to meet international medical device standards. You will partner with operations to ensure compliance and foster a culture of continuous improvement.

Required skills

Quality Assurance

Procedures

Validation

Analytical Skills

Documentation

Alignment

implementation

CAPA

Operations

Chemistry

Regulatory Compliance

Investigations

Teams

Driving

UPS

Communication Skills

QMS

ISO 13485

Dutch

English

Strategy

Support

Regulatory Standards

Certification

Production

Batch Release

Vision

External Audits

medical device standards

Performance Metrics

Make

Training

ISO 9001

Auditing

Management

Serving

Proactive

Listening

Attention

In this role, you will be instrumental in maintaining and improving our Quality Management System (QMS) in alignment with ISO 13485 and other regulatory standards. You will serve as a quality partner to operations, driving compliance, supporting product and process changes, and promoting continuous improvement across the organization.

Responsibilities

•

Maintain and enhance the Quality Management System (QMS) in compliance with ISO 13485 and relevant regulatory standards.

•

Support the implementation of new or updated products, processes, and procedures, ensuring regulatory and quality alignment.

•

Manage non-conformities, complaints, and CAPAs, ensuring thorough investigations, timely follow-ups, and proper documentation.

•

Plan, coordinate, and conduct internal and supplier audits; actively support external audits and regulatory inspections.

•

Provide training and coaching to colleagues on quality standards, procedures, and best practices.

•

Contribute to Management Reviews and monitor key quality performance metrics, identifying opportunities for improvement.

•

Review and approve production batch releases, validation protocols, and validation reports.

•

Offer hands-on quality support to operational teams on the production floor, ensuring compliance in daily activities.

Requirements

•

Bachelor’s or Master’s degree in Engineering, Biomedical Sciences, Chemistry, or a related field.

•

1–3 years of experience in a Quality Assurance or Regulatory role, preferably in medical devices or a regulated industry.

•

Knowledge of ISO 9001 is required; experience with ISO 13485 is a strong advantage.

•

Auditing experience or certification (e.g., ISO 13485 Lead Auditor) is a plus.

•

Fluent in Dutch and English, both written and spoken.

•

Available to work on-site in Vierpolders full-time (five days a week).

•

Strong analytical skills with high attention to detail.

•

Proactive, quality-driven mindset focused on continuous improvement.

•

Excellent communication skills and ability to collaborate effectively across departments.

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