Senior Quality Assurance Expert
We are seeking an accomplished Senior Quality Assurance Expert to lead our quality initiatives and contribute to the development of our quality systems. This role requires a seasoned professional with extensive experience in quality assurance and regulatory compliance.
Key Responsibilities:
* Develop and maintain quality systems in compliance with ISO 13485:2016 and 21CFR Part 820.
* Manage document control, ensuring all documents are processed consistently and compliantly.
* Represent the quality function at team meetings, providing advice and completing documentation reviews in a timely manner.
* Participate in risk management processes to ensure risks are captured and mitigated according to ISO 14971:2019 requirements.
* Liaise with technical operations to support device manufacture, ensuring high-quality products are delivered in compliance with procedures and regulations.
* Prepare quality system metrics for management meetings and review.
* Address customer complaints in compliance with relevant regulations, adhering to vigilance and reporting requirements.
* Implement and manage CAPA systems, addressing observations in accordance with procedures.
* Ensure Computerised System Validation is performed as per documented procedures and regulations.
* Maintain internal audit systems, completing audits on schedule and addressing non-conformances and recommendations.
* Support supplier management programs, ensuring sub-contractors, suppliers, and external parties meet quality system requirements.
* Prepare reports, documents, procedures, specifications, and other technical documents as required.
* Spearhead quality system process improvements and business enhancements.
Requirements:
* Bachelor's degree in Science or Engineering is a prerequisite.
* A minimum of eight years' experience in quality engineering or regulatory roles, preferably in the medical device industry.
* Excellent written, interpersonal communication, and presentation skills, with the ability to present information effectively to peers.
* A self-starter who can drive work towards advancing company goals with minimal direction.
* Exceptional communication skills, able to understand virtually everything heard or read, summarize information, and reconstruct arguments.
* A solid grasp of team dynamics, enabling participation in teams delivering outstanding results.
* Holds themselves and others accountable by following through, acting with ownership, and taking personal responsibility for decisions, actions, and failures.
* Able to prioritize critical objectives among numerous project tasks and activities.