Careers

• Accountable for ensuring full quality and regulatory compliance of a facility including having solid QMS in place, while driving process effectiveness and efficiency at the site.

• Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews.

• Proactive identification and alerting of quality issues in time to resolve potential adverse effects to the customer.

• Define approach and governance quality system internal audit program including training of auditors.

• Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters.

• Drive continuous improvement of Supplier Quality functional competence and maturity through coaching, mentoring and promotion of best practice. 

• Analyze and communicate regulatory trends and their implications for the site; develop & implement effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements and acts as PRRC (Person Responsible for Regulatory Compliance).

• Lead and support continuous improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, metrics development and implementation.

• Product verification & testing

• Lead analytic tests

• Bachelor’s degree in Engineering or life sciences.

• Minimum 3 years Quality Assurance/Regulatory experience as QA/RA manager in 
    a medical device company. (medical diagnostics preferred).

• Demonstrated knowledge of regulatory issues, and experience interfacing with local &   international regulatory bodies, such as FDA, European competent authorities & notified   bodies, Health Canada, etc.

• Experience of routine QA/QC activities: CAPA, MRB, ECO, RMA, SCAR.

• Demonstrated management skills; ability to prioritize, plan, evaluate & execute
    deliverables for established tactical goals.

• Technical understanding and hands-on skills

• Ability to lead analytic tests.

• Demonstrated knowledge of Quality Management System tools, continuous improvement
    methodologies & in-depth understanding of site level products & related processes.

• English Proficiency

• Dedicated, organized person.

Please send CVs to info@gyntools.com

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