Sr Quality Engineer

Posted Yesterday
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Cartago, Cartago, CRI
In-Office
Senior level
Healthtech
The Role
Support manufacturing and new product development by identifying process defects, leading quality release activities, performing root cause analysis and CAPA, supporting validations (IQ/OQ/PQ), working with R&D and suppliers on qualification and sampling, and training on complaints handling using GCS2.
Summary Generated by Built In

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.

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:

Provide Process/Quality Engineering support to manufacturing or new product development teams, helping to ensure delivery of highest quality product or new products to the customer.

Your Responsibilities Include:

· May execute the following resposibilities:

· 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. May be responsible for working with process owner to bound product stops and document release criteria.

· 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.

· Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.

· Becomes familiar with Product/Process improvement efforts by understanding current quality metric 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.

· Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

· Manage and lead the quality release area.

· Supervisory responsibility over the Quality Release team.

· Evaluates new equipment and processes and participates in the transfer of new products.

· Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.

· Read and interpret technical drawings, procedures, and protocols

· Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).

· Document investigation findings in analysis report on GCS2

· Become a trainer for the Software related with complaints handling process (GCS2), as required.

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

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

What We’re Looking For:

· Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.

· English Level desired: B2:(80-89%).

· Desired knowledge: Formal Training on statistical and quality techniques desirable, ASQ Certified, Knowledge of Six Sigma, APQP or similar tools.

· At least 5 years of experience in similar position.

Requisition ID: 633185

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.

#CRTA #CTGTA 

Skills Required

  • Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related field
  • At least 5 years of experience in a similar quality engineering position
  • Supervisory experience or ability to manage the Quality Release team
  • Experience with equipment and process validations (IQ/OQ/PQ) and validation documentation
  • Ability to read and interpret technical drawings, procedures, and protocols
  • Familiarity with CAPA, NCEP, Failure Mode Investigations and documenting investigation findings (GCS2)
  • English level B2 (80-89%)
  • Formal training in statistical and quality techniques; ASQ certification, knowledge of Six Sigma, APQP or similar tools

Boston Scientific Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.

  • Healthcare Strength Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
  • Retirement Support Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
  • Leave & Time Off Breadth Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.

Boston Scientific Insights

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The Company
HQ: Marlborough, MA
52,374 Employees
Year Founded: 1979

What We Do

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.

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