Senior Quality Assurance Engineer (Alajuela, Costa Rica)
DEU - Smith & Nephew GmbH
Apply to this jobLife 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...
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Summary
Support quality processes, risk management, validation, CAPA, and process improvements in medical devices.
Job title
Senior Quality Assurance Engineer
Experience level
more than 5 years
Minimum experience
5+ years exp
Industry
medical device
Location requirements
On-site in Alajuela, Costa Rica, flexible remote options
Salary
Not specified
Management role
No
Required skills
Preferred skills
Specializations
Structured locations inferred from the posting.
Alajuela Province, Coyolar, Costa Rica
Unknown location