Quality Specialist II

hace 1 mes


San José, Costa Rica Smith+Nephew A tiempo completo

Life Unlimited. At Smith and Nephew we design and manufacture technology that takes the limits off living. 

Are you looking for a new opportunity to grow? This position is responsible for implementing, supporting, and sustaining elements of the Quality System. The Quality Specialist II serves as a Quality Systems resource for ISO, EN, MDSAP, MDD, EU MDR, NMPA, J-GMP, QSR, and other regulatory requirements for the Austin, TX site. This role provides oversight and mentorship in Quality Systems operations, ensuring continuous compliance to external standards/regulations and internal requirements, and assisting globalization of requirements, where vital.

Responsibilities are carried out with reasonable discretion and independent judgment as required. The position will provide support to all elements within the Quality Management 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): P2
 

What will you be doing?

Provide leadership, Quality oversight and decision-making 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. Lead and/or 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. Assist in the Quality oversight of the CAPA process to ensure robustness of investigations and resulting corrections/corrective actions. Provide training to enhance investigations and knowledge of controlled document system. Serve as the controlled document system Quality Administrator and actively work with CAPA owners throughout the CAPA lifecycle. 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.


What will you need to be successful?

Education: University degree in science, engineering, or other related field. ISO 13485 Lead Auditor Certification, Certified Quality Auditor preferred. Experience: Minimum 2-3 years of experience in Quality in the pharma/medical device industry or similar regulated industry. Experience in leading teams, organizing, and handling projects and/or developing/coaching/guiding junior team members. Strong Statistical application experience is desirable. Languages: proficient English language skills, oral and written. Knowledge: Microsoft Office products (e.g., Word, Excel and Project). Experience with Agile, Smart Solve, Windchill and SAP 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.). Ability to provide and implement solutions to Quality problems. Analytical skills and problem-solving techniques are required.

You. Unlimited

We 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…

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