Quality Systems Sr. Specialist

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

Are you ready to take the next step in your career?

This position is a hybrid role for a Quality Systems Sr. Specialist based in Costa Rica and supporting remotely the Quality Management System (QMS) of the Design Center in Austin, TX. You will be responsible for implementing, supporting, and sustaining elements of the QMS, while also serving as a resource for ensuring compliance to ISO, EN, MDSAP, MDD, EU MDR, NMPA, J-GMP, QMSR, and other regulatory requirements for the Austin, TX site.

This position is P3 level

What will you be doing?

• Provide leadership, Quality oversight and decision making for Quality Systems processes (e.g., NC/CAPA, internal/external audits, 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 CFR 820, ISO 13485, MDD, EU MDR, etc.). Provide training as necessary to support these QMS policies and procedures.
• Lead the preparation and coordination of internal/external audits. Support the execution of audits as needed (e.g. facilitator, reviewer, SME, etc.). Assist in the response resolution of resulting findings and tracking of these response commitments.
• Maintain key Quality metrics/indicators to track performance and compliance and analyze data to develop and implement improvements to streamline and improve process and procedures. Lead the preparation of the Management Review meetings.
• Establish and maintain successful cross-functional relations with R&D, Engineering, Manufacturing, Marketing, Clinical Services, Quality and Regulatory Affairs departments.
• Assist in other responsibilities requested by Management to ensure compliance, support Training Coordination and Doc Control activities as required.

What will you need to be successful?

Required Qualifications

Education:

• Bachelor's degree in Science, Engineering, or other related disciplines.

Experience:

• Minimum 5 years of experience in Quality and/or Compliance in the pharma/medical device industry or similar regulated industry.
• Demonstrated experience in leading teams, organizing, and managing projects and/or developing/coaching/guiding junior team members.

Languages:

• Proficient English language skills, oral and written.

Knowledge:

• Demonstrated ability to understand the impact of regulatory requirements (e.g., GMPs, ISO 13485, MDSAP, J-GMP, MDD, EU MDR, NMPA, etc.).
• Working knowledge of Microsoft Office products (e.g., Word and Excel).

Competences:

• Effective written/oral, interpersonal, organizational skills.
• Demonstrated ability to provide and implement solutions to Quality problems.
• Strong analytical skills and problem-solving techniques are required.

Preferred Qualifications

Certifications:

• ISO 13485 Lead Auditor Certification / Certified Quality Auditor.

Experience:

• Audit front room/back room experience.
• Experience with Agile, SmartSolve, Windchill and SAP.

Knowledge:

• Statistical application experience.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website

• 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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