Quality assurance expert

Job Title: Quality Assurance Expert

Our organization is seeking a Quality Assurance Expert to oversee quality systems, internal manufacturing processes, and supplier relationships.

This role will report directly to the Chief Operating Officer (COO) and be responsible for maintaining the company's Quality Management System (QMS), supervising quality technicians, and managing quality system aspects.

* Maintain QMS, provide regular performance reports to Senior Management.
* Supervise quality technicians, ensure timely completion of departmental activities and objectives.
* Oversee quality system aspects, including management reviews, quality reviews, and internal audit programs.
* Manage supplier relationships, conduct audits, monitor performance, and negotiate quality agreements.
* Lead manufacturing validation efforts, including MVP development, PFMEAs, validation protocols, and reports.
* Address customer complaints, analyze reports, and identify complaint trends.
* Investigate and resolve Corrective Action Preventative Actions (CAPA) and Non-Conformity Reports (NCRs).
* Coordinate lot release procedures, ensuring routine sterilization and adherence to regulatory requirements.
* Prepare for and lead external audits, including those from FDA and Notified Bodies.
* Provide QA support to Operations, ensuring quality, cost, and output objectives are met.

* Bachelor's degree in a scientific discipline or equivalent experience (4 years minimum) in the medical device or pharmaceutical industry.
* Strong analytical skills, exceptional writing, and interpersonal relationship skills.
* Demonstrated knowledge of ISO 13485 and 21 CFR 820 regulations.
* Ability to work effectively within a team, meeting targets and goals efficiently.
* Excellent organizational, management, and communication skills.

Benefits include opportunities for professional growth and development, as well as collaboration with experienced professionals in the field. If you possess a strong understanding of quality principles and have excellent analytical and communication skills, we encourage you to apply for this exciting opportunity.