CR-Quality Engineer II in Alajuela, Alajuela at Theragenics Corp

Quality Engineer ll

Onsite position

Alajuela, Provincia de Alajuela, CR

Theragenics is a leading innovator in the medical device industry, dedicated to advancing patient care through cutting-edge technology and unwavering commitment to quality. We seek talented professionals who are driven to contribute to meaningful healthcare solutions in a dynamic, growth-oriented environment. Join our team and help shape the future of medical device excellence.

We are seeking candidates at multiple experience levels with GMP and ISO 13485. Theragenics offers substantial long-term career development opportunities within our rapidly expanding engineering organization.

The Role:In this role, you will be responsible for establishing and improving quality assurance practices and procedures. You will lead the evaluation of quality sampling plans and inspection methods, while reviewing and recommending strategic solutions to quality challenges. This position is key to developing, implementing, and maintaining quality system elements that ensure the highest standards for both existing products and new products transferred to the site. This role offers the opportunity to develop deep technical expertise and potentially advance into leadership or specialized quality compliance roles as the company grows.

RESPONSABILITIES

· Lead and/or support process, product and/or equipment validation transfers, and design process activities (e.g., IQ, OQ, PQ, etc.). Execute equipment and process validation activities as required.

· Review and ensure validation protocols as well as monitor quality policies regarding the transfer and validation processes of processes/products.

· Provide manufacturing on-the-line Quality support.

· Investigate instances of nonconforming material and facilitate the determination of root cause, correction action/preventive action (internal &supplier), and recommendation of disposition (Material Review Board).

· Write procedures necessary for implementing quality requirements

· Utilizes DMAIC tools to promote a disciplined non-conformance investigation approach and participates in corrective and preventive actions (CAPA)related activities, including CAPA ownership if appropriate.

· Design means for measuring accuracy and documenting of inspection work

· Evaluate and recommend inspection gauges and test equipment

· Evaluate incoming raw material acceptance plans for effectiveness and validity

· Participate with manufacturing to recommend in-process and final inspection strategies to assure product quality at each stage of manufacturing.

· Ensure appropriate use of sampling plans and evaluate statistical rationale of acceptance plans at all stages of design and manufacturing

· Audit processes, internal and supplier, for quality and regulatory compliance and recommends improvements based on analysis of data and system performance

· Collaborate with suppliers to ensure the quality of incoming materials and components

· Develop key indices of measurements for quality, cost and delivery and improve cycle times

· Leads or assists in process improvement projects and provides technical input and assistance in activities such as Quality planning, Risk analysis, FMEA.

· Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other QA engineering areas (once he obtains Minitab training and ASQ certification).

· Write, review and performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols

EDUCATION:

· Bachelor's degree from four-year college, university, or 4 years related experience, and/or training or equivalent combination of education and experience.

· Working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements

· ASQ CQE/CSSBB is considered a plus.

· English B2

EXPERIENCE:

· Previous experience in Quality in a regulated industry, 2-3 years specifically in a medical device environment.

· Hands-on experience in validation activities, including process validation, equipment qualification, and protocol development.

· Preferred: Knowledge of statistical analysis tools and familiarity with equipment and process validation.

· Familiarity with Minitab or any equivalent statistical tool is required.