Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health.That is why we stand for inclusion, equality, and opportunity for all.By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity, and inclusion excellence.Also, we have a Gender Equality Policy to support our commitment.Hybrid Roles: Boston Scientific's hybrid workplace includes WFH and onsite.You will have the opportunity to discuss details in the interview.About the role: The Quality Engineer II is responsible for monitoring and improving manufacturing processes to ensure product and processes performance according to applicable standards and regulations.He or she should support verification/validation activities and should also have a limited supervision role.Your Responsibilities Include: With the help and mentoring of Quality Dept.Head and Sr. Quality Engineering personnel, identify, implement, and monitor effective process controls to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements: QE for products from the incoming, in process and final inspections.Lead the implementation of process controls, NCR actions, Process Improvement, Problem Solving and CAPA systems designed to meet or exceed internal and external requirements.Lead Problem Solving, scope definition and disposition of material during a non-conforming event.Act as team member in supporting quality disciplines, decisions, and practices.Apply solid, systematic problem-solving methodologies in identifying, prioritizing, communicating, and solving quality issues.Advise management on potential improvements or enhancement to quality systems and processes in the production lines and company.Understand, interpret, and apply Apollo Endosurgery Quality Management System principles and processes to ensure compliance with Corporate and Regulations and Standards with unyielding integrity.Ensure awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Apollo Endosurgery.Provide support in the following areas: Support compliance activities.Support complaint investigations.Support risk analysis for new processes and products.Support process validation activities.Supports corrective actions/ preventive actions (CAPA).Other duties may be assigned.What We're Looking For: Licentiate or bachelor's degree in mechanical engineering, Electromechanical Engineering, Chemical Engineering, Materials Engineering, Chemical Industrial Engineering.Experience in Quality Engineering with Class II and Class III medical devices strongly desired.Strong quality management experience, minimum 3+ years of experience in Quality Systems / Quality Engineering.Evidence of practical knowledge of standards and regulations pertaining to the medical device industry.Knowledge on product and process qualification and validation.Expertise developing and implementing metrology-based engineering solutions.Ability to interpret technical drawings that may include mechanical dimensioning and Geometric Dimensioning and Tolerance (GD&T).Strong knowledge of Measurement, inspection techniques, Test tools e.g.calipers, micrometers, Vision Systems (Smart Scope, Micro Vu) and statistical methods (Gage R&R, DOE, process capability, etc.).Strong knowledge in MSA.Competency Level Developing role to gain experience and develop increased capability and competency.Knowledge – An experienced professional with a good working and background knowledge of area of practice; resolves a wide range of issues in innovative ways.Standard of Work – Fit for purpose, though may lack refinement.Autonomy – Normally receives little instruction on day-to-day work, general instructions on new assignments.Coping with complexity – Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.Demonstrates good judgment in selecting methods and techniques for obtaining solutions.Networks with senior internal and external personnel in own area of expertise.Perception of context – limited – Sees actions at least partly in terms of longer-term goals.Strong written and oral English skills (B2 level at least).Availability to work in Shift B. Requisition ID: 585013 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.
