Quality Specialist I (Coyol, Alajuela)

Título del trabajo: Quality Specialist I (Coyol, Alajuela)

Compañía: Smith & Nephew

Descripción de funciones: Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.Are you looking for a new opportunity where you can put into practice all your knowledge? The Quality Specialist I is primarily responsible for serving as Training Coordinator and SME for the Austin, TX site, conducts the training set-up in the change control system, runs training requirements based on the inputs of the applicable people managers, facilitates training as required to provide access to change control systems and monitors personnel training metrics.This role pursues compliance with ISO, EN, MDSAP, MDD, EU MDR, NMPA, J-GMP, QSR, and other regulatory requirements while supporting the elements of the Quality System, including but not limited to internal and external audits, NC/CAPA, document control/records, training, and external standards’ monitoring. They establish and maintain successful cross-functional relations with Materials, R&D, Engineering, Manufacturing, Marketing, IT, Finance, Sales, Quality, and Regulatory Affairs departments.Job level (for internal use only): P1What will you be doing?

• Act as the Training Coordinator and SME for the Austin, TX site. Conduct the training set-up in the change control system, run training requirements based on the inputs of the applicable people managers, facilitate training as required to provide access to change control systems, and supervise personnel training metrics.
• Provide Quality oversight for Quality Systems processes (e.g., NC/CAPA, internal audits, external inspections, standards/regulations, training, document control, etc.). Develop and implement solutions for issues and non-conformances related to Quality Systems processes.
• Support compliance and process improvement initiatives related to the QMS.
• Review, update and implement changes to procedures to ensure compliance to regulations and standards (e.g., 21 CR 820, ISO 14385, MDD, EU MDR, etc.). Provide training as vital to support these QMS policies and procedures. Effectively support and follow policies and procedures.
• Assist in the preparation and coordination of internal audits and external inspections. Assist in the response resolution of resulting findings and tracking of these response commitments.
• Maintain key Quality metrics/indicators to supervise performance and compliance and analyze data to develop and implement improvements to streamline and improve processes and procedures. Assist in the preparation of Quality Systems metrics for Management Review meetings.
• Assist in other responsibilities requested by management to ensure compliance.

What will you need to be successful?

• Education: Bachelor’s degree in science, engineering, or other related field.
• Experience: 1 year of experience in Quality in the pharma/medical device industry or similar regulated industry preferred.
• Experience with Agile, SmartSolve, Windchill and SAP is desirable.
• Languages: proficient English language skills, oral and written.
• Knowledge: Microsoft Office products (Word, Excel and Project) is required.
• Strong analytical skills and problem-solving techniques.
• Statistical application experience is desirable.
• Competencies: Effective written/oral, interpersonal, and organizational skills.
• Ability to understand the impact of regulatory requirements (e.g., GMPs, ISO 13485, MDSAP, J-GMP, MDD, EU MDR, etc.).
• Capable to provide and implement solutions to Quality problems.

You. UnlimitedWe believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about on our website.Other reasons why you will love it here!

• Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.
• Work/Life Balance: Extra days off, birthday off, voluntary hours.
• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave.
• Flexibility: Hybrid work model (for more professional roles), flexible schedules.
• Training: Training program, unlimited learning.
• Extra perks: employees association, and more…

#LI-HYBRIDStay connected and receive alerts for jobs like this by joining our .We’re more than just a company – we’re a community! Follow us on to see how we support and empower our employees and patients every day.Check our for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.

Ubicación: Alajuela

Fecha del trabajo: Wed, 29 May 2024 04:04:34 GMT


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