Senior Quality Assurance Engineer (Alajuela, Costa Rica)

Reposted One Month Ago
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Alajuela, San José, Coyol, CRI
In-Office
Senior level
Healthtech • Biotech
The Role
Lead and support quality engineering activities for medical device manufacturing: sampling plans, tolerances, inspection methods, GR&R, validations, CAPA and non-conformance resolution, training, failure analysis, continuous improvement, and customer-complaint response.
Summary Generated by Built In

Life Unlimited. At Smith+Nephew we design and manufacture technology that removes the limits of life.

Are you passionate about quality? In this position you will be responsible for providing support and planning, controlling, and ensuring the quality of products, processes, and validations in accordance with the quality regulations and standards governing the manufacture of medical devices.

What will you be doing?

  • Provide support in quality statistics and engineering, including sampling plans, dimensional tolerances, inspection methodologies, GR&R analyses, validations, qualifications, and transfers.

  • Manage and provide support for the resolution of product-related Non-Conformances. Additionally, implement and deliver training on the Non-Conforming Product Control and quarantine process.

  • Provide support for the generation and resolution of Corrective and Preventive Actions (CAPA) related to products and processes associated with the manufacturing operation.

  • Coordinate and provide support for continuous improvement processes in manufacturing processes as well as in inspection/quality processes.

  • Coordinate failure analyses, corrective and preventive actions to respond to customer complaints.

What do you need to succeed in this position?

  • Education: Bachelor's degree in Engineering or related field.

  • Licenses/certifications: Desirable certification as Quality Engineer (e.g., CQE from ASQ).

  • Desirable Green Belt and/or Six Sigma Black Belt certification.

  • Experience: More than 5 years of prior experience in Quality Engineering positions in the Medical Device Industry or related field.

  • Languages: Advanced English (B2+).

  • Other: Microsoft Office proficiency.

  • Statistical software proficiency.

  • Competencies: Working under multiple demands, sense of urgency, good interpersonal relationships, analytical reasoning, proactivity, assertive communication, negotiation skills, attention to detail, and adaptability to change.

You.Unlimited.

Inclusion, Diversity and Equity- Committed to welcoming, celebrating and thriving on diversity. Learn more about Inclusion Groups on our website.

Other reasons why you'll love being here

  • Your finances: stock purchase program, referral bonus, transportation and food subsidy, recognition program

  • Work/life balance: Additional days off, birthday off, volunteer hours

  • Your wellbeing: Company physician, gym, life insurance, health campaigns, legal, psychological and financial assistance program

  • Flexibility: Flexible schedules, possibility of remote work depending on role functions

  • Training: Training programs, unlimited learning tools

  • Extra benefits: Employee Association and more...

#LI-ON-SITE

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  


Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer. 

Skills Required

  • Bachelor's degree in Engineering or related field
  • More than 5 years' experience in Quality Engineering in the Medical Device industry or related field
  • Advanced English (B2+)
  • Microsoft Office proficiency
  • Statistical software proficiency
  • Certified Quality Engineer (e.g., CQE from ASQ)
  • Green Belt and/or Six Sigma Black Belt certification

Smith & Nephew Compensation & Benefits Highlights

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

  • Healthcare Strength Medical, dental, and vision plans are paired with a global mental‑health program for employees and families, indicating a robust core health package.
  • Retirement Support U.S. employees have access to a 401(k) with company contributions, and share plans complement long‑term savings.
  • Leave & Time Off Breadth Generous holiday, paid volunteering leave, and flexible work models point to broad time‑off options.

Smith & Nephew Insights

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The Company
Andover, MA
15,318 Employees

What We Do

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude, we work together to win.. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. Please note: not all products referred to may be approved for use or available in all markets.

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