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Tier-1 brand, mid-level QA role and metro location attract many qualified applicants.
Medtech regulatory and design control expertise strongly limits cross-industry transferability.
Mandatory 6+ years medtech experience and regulatory quality expertise creates strict hiring filters.
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Implement and guide comprehensive process validation plans for effective new product transitions to production under general supervision.
Manage and ensure compliance of design control processes including validation, verification, and design transfer in line with regulatory and quality standards.
Lead quality improvement projects, conduct root cause analysis, apply risk management, and support quality audits to maintain adherence to internal and external standards.
6+ years of experience in the Medtech industry.
Degree in any Engineering discipline.
Proven skills in process validation, design control, quality engineering documentation, risk management, and post-market analytics.
Onsite role requiring full-time presence at company facilities (office-based at least 3 days per week).
Experienced in managing medium to high complexity quality engineering issues within Medtech product lifecycles.
Skilled in integrating quality, reliability, and post-market surveillance into continuous product quality improvement initiatives.
Proficient in regulatory compliance related to medical device design control, validation planning, and quality audit preparation.