Additional Locations: N/A 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: Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system.
Understands and complies with all the regulations governing the quality systems.
Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
You're Responsibilities include: Lead Products & Processes Transfers from a Quality standpoint.
Identifies and resolves complex exceptions to work assignments.
Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
Read and interpret technical drawings, procedures, and protocols.
Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.
Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
Participates in Customer Complaints investigation for areas under their control.
Continually seeks to drive improvements in product and process quality.
Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Evaluates new equipment and processes and participates in the transfer of new products.
Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.
May be responsible for learning risk analyses and FMEAs.
Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
Get involve in various stages of equipment and processes validations: Run and/or review and approve reports: TMVs, I.Q 's, O.Q's and P.Q's as well as any other document relating to validation.
Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
Responsible for reviewing and developing process validation protocols and reports.
Support other functional areas during the validation activities.
Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
Knowledgeable on Risk Management, ISO EN 14971 requirements.
May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
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 auditing process.
What We're Looking For: Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
English Level desired: B2 (80-89%) Experience: proven experience in Medical or Pharmaceutical industry, working on Quality, Process Development or Engineering Department.
Solid knowledge in Statistics, Problem Solving techniques, Quality System, Process and Test Method Validation, Risk Management, Six Sigma or similar.
Desired knowledge: Product and Process Transfer and Project Management.
ASQ certified desired.
At least 3 years of proven experience in similar position .
Requisition ID: 595670 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 which we operate.
Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal.
And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
Benefits • Life-Work Integration • Community • Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.
With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges.
Together, we're one global team committed to making a difference in people's lives around the world.
This is a place where you can find a career with meaningful purpose—improving lives through your life's work.