Are you a quality expert looking for a new challenge? We have an exciting opportunity for a Quality Assurance Specialist to join our team.
About the Role:
This is a critical role in ensuring that medical devices meet the highest quality and regulatory standards throughout the product lifecycle. As a Quality Assurance Specialist, you will play a key part in supporting sustaining engineering projects by providing Design Assurance expertise.
Responsibilities:
1. Evaluate and support the implementation of product, process, and material changes within manufacturing operations. Conduct patient risk assessments related to proposed design changes.
2. Collaborate with R&D and Manufacturing Engineering teams to ensure robust quality standards are implemented and maintained. Generate and manage Design Verification protocols.
3. Partner with Regulatory Affairs to ensure clear, accurate, and complete information is presented in submissions to minimize regulatory queries. Lead investigation activities, root cause analysis, and timely resolution of quality issues.
4. Design or specify inspection and test methods, equipment, and quality assurance procedures. Conduct QA testing and statistical analysis as required.
5. Ensure that corrective and preventive actions (CAPA) are implemented effectively and documented in accordance with regulatory and quality standards.
6. Achieve specialization in one or more quality disciplines including design, incoming inspection, production control, product evaluation, reliability, inventory control, or R&D quality support.
Requirements:
* Bachelor's degree in Engineering, Science, or a related technical field.
* Minimum of 5 years' experience in a Quality Assurance or Design Assurance role within the medical device industry.
* In-depth knowledge of ISO 13485, 21 CFR Part 820, and other applicable global medical device regulations and standards.
* Demonstrated experience with design control, risk management (ISO 14971), validation/qualification activities, and root cause analysis.
* Strong written and verbal communication skills; experience interfacing with regulatory bodies is a plus.
* Proficient in statistical tools and quality methodologies (Six Sigma, CAPA, FMEA).
* Ability to manage multiple priorities and work effectively in a collaborative, fast-paced environment.
We Offer:
* A dynamic and supportive team environment.
* Ongoing professional development opportunities.
* A competitive compensation package.