Quality Manager (Medical Devices)
We are seeking a Quality Manager who thrives in a fast-paced, multidisciplinary environment. This is an opportunity to play a pivotal role in shaping quality systems that directly enhance patient outcomes. We’re looking for a proactive and detail-oriented individual who is passionate about delivering high standards in medical device quality and compliance.
Key Responsibilities:
* Apply quality engineering principles across the Quality Management System (QMS), including design controls, verification and validation, risk management, and supplier quality.
* Lead the Management Review process, including the development and monitoring of key performance indicators (KPIs) and quality objectives.
* Manage regulatory reporting activities and ensure timely and accurate submissions to relevant authorities and internal stakeholders.
* Oversee the implementation, certification, and maintenance of ISO 13485 and QMSR compliance, ensuring audit readiness.
* Lead and maintain design history files (DHFs), support test method development and validation, and collaborate on usability engineering and risk management processes.
* Develop and validate computer system validation/assurance programs to ensure compliance with regulatory expectations.
* Act as a key liaison across departments to promote quality culture and alignment with strategic objectives.
* Manage customer feedback processes, including complaint handling and root cause investigations.
* Administer document control systems (e.g., QT9 or equivalent eQMS) and ensure proper documentation practices.
* Drive non-conformance (NC) and corrective/preventive action (CAPA) processes to closure.
* Support internal and external audit programs and facilitate timely resolution of findings.
* Monitor regulatory and industry standards, performing gap analyses and recommending updates to support product compliance.
* Lead supplier quality management activities, including supplier evaluation and ongoing performance monitoring.
* Ensure integrity and completeness of Device Master Records (DMRs) and Device History Records (DHRs).
* Perform lot release responsibilities as needed.
* Support quality team development, including training, competency evaluation, and performance reviews.
* Contribute to broader business objectives through quality-driven initiatives.
Candidate Profile:
* Bachelor’s degree (or equivalent) in science, engineering, or a related technical field.
* Minimum of 5 years’ experience in a medical device environment.
* Solid knowledge of GMP, FDA QMSR, ISO 13485, and relevant global regulatory frameworks.
* Experience working in both U.S. and European regulatory environments is advantageous.
* Strong problem-solving and decision-making skills, with familiarity in methodologies such as DMAIC.
* Working knowledge of ISO 14971 risk management practices.
* Experience in quality systems, supplier quality, regulatory affairs, or design assurance is beneficial.
* Familiarity with sterilization methods (Ethylene Oxide, Gamma), biocompatibility, packaging, labeling, and transportation standards is a plus.
* Previous audit experience (internal or external) is advantageous.
* Proficiency in Microsoft Office tools is required.
Why Join Us?
You’ll have the opportunity to contribute to meaningful innovation in healthcare while growing professionally within a dynamic, supportive environment. This role offers the chance to influence product development, operational excellence, and patient safety from the ground up.
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