Sr Packaging Quality Engineer #4386
ECI
Fecha: hace 3 semanas
ciudad: Alajuela, Alajuela
Tipo de contrato: Tiempo completo
Brief Description
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role
The Sr Packaging Quality Engineer is responsible for ensuring the integrity, compliance, and continuous improvement of packaging systems and processes within the medical device industry. This role focuses on leading validation activities, test method development and validation (TMD/TMV), and packaging verification aligned with applicable standards (ISO 11607, ASTM, ISO 17025). The Sr. QE will act as a key technical resource for quality systems in the packaging laboratory and interface with cross-functional teams to support new process development, sustaining projects, and regulatory audits.
What You'll Do
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role
The Sr Packaging Quality Engineer is responsible for ensuring the integrity, compliance, and continuous improvement of packaging systems and processes within the medical device industry. This role focuses on leading validation activities, test method development and validation (TMD/TMV), and packaging verification aligned with applicable standards (ISO 11607, ASTM, ISO 17025). The Sr. QE will act as a key technical resource for quality systems in the packaging laboratory and interface with cross-functional teams to support new process development, sustaining projects, and regulatory audits.
What You'll Do
- Lead packaging validation efforts (installation, operational, and performance qualifications - IQ/OQ/PQ) for sterile and non-sterile barrier systems.
- Oversee and/or conduct Test Method Development and Validation (TMD/TMV) to ensure compliance with ISO 11607 and ISO 17025.
- Ensure packaging designs and testing meet applicable regulatory and quality standards (FDA, ISO, MDR).
- Serve as the subject matter expert (SME) for packaging test methods such as burst, dye penetration, seal strength, transit simulation, aging, and environmental conditioning.
- Author, review, and approve quality documentation, including protocols, reports, nonconformance investigations, risk assessments, and CAPAs.
- Support internal and external audits as the representative of the packaging lab function.
- Provide technical mentorship and support to junior engineers and lab technicians.
- Drive continuous improvement projects within the packaging lab to enhance testing efficiency, accuracy, and regulatory readiness.
- Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules under supervision.
- Providing mentorship and work direction to junior-level engineers, engineering technicians and other cross-functional support personnel.
- Partner with Operations to ensure robust packaging solutions for new and existing services.
- Analyze packaging failures and lead root cause investigations.
- Ensure calibration and maintenance of lab equipment and adherence to GLP/GMP principles.
- Bachelor’s Degree in Engineering.
- 9+ years of experience.
- Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio) Proficient in the use of Minitab statistical analysis.
- Experience with SolidWorks, ProE or Inventor, prototypes, 3D (desirable).
- Familiar with electronic management documentation systems (desirable).
- Familiar with electronic management documentation.
- Spanish: Native Speaker, English: Fluent speaking, writing and reading
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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