Senior Quality Engineer

Recruiter: Francisco Munoz Munoz   Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace. About the Role:   Provide Design Quality Engineering support helping to ensure delivery of highest quality product or new products to the customer.   Your Responsibilities Include

Lead Products from a Design Quality standpoint.

Identifies  and resolves complex exceptions to work assignments.

Summarizes, analyses, draws conclusions and makes  appropriate decisions from test results or other related findings.

Read and interpret drawings, procedures, and protocols.

Deep understanding of documents  and systems by reviewing product specifications, quality specifications, and working with quality systems.

Responsible for  the creation and maintenance of the Risk Documentation.

Becomes familiar with Product/Process improvement efforts by understanding current data and learning the various analysis methods used to enhance sustaining product design and new product development.

Learns  Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing &  utilizing  available training materials.

Owns and provides support in CAPAs, NCEP, Complaints Analysis, Field Assessments, PIRs, Field Actions, Failure Mode Investigations, etc.

Compiles and analyses test  and validation data to  establish  technical specifications and performance standards for newly designed or modified products and processes.

Responsible for reviewing and developing  test methods  validation protocols and reports. Support other functional areas during  the validation  activities.

Knowledgeable on  Risk Management, ISO EN 14971 requirements.

Uses  knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.

Gives technical guidance to other members of the team.

Is a good team member, fully motivated to achieve and  demonstrate  best practices in line with the department and Site  objectives .

Is familiar with the internal and external auditing  process.

Work with Research and Development to efficiently qualify new components;  assist  suppliers in creating statistical sampling plans, inspection  methodology  and quality procedures for new components.

Provide support on all the activities  related  the post market surveillance.

Support on design changes activities.

Bachelor degree or above in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field. English Level desired: Advanced (minimum) At least 5 years of experience in similar position

Strengths

Good building relations. Stakeholders handling. Communications skills. Coordination with other areas  A high percentage of the day is dedicated to meetings  Providing Guidance to junior partners.  Leadership.  Collaboration.  Product design experience (Desirable).  Statistics knowledge (Desirable). Experience leading teams (Desirable).

Requisition ID:  631271   As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in