Quality Assurance Leader
Our organization is seeking a Quality Assurance Leader to oversee quality system, internal manufacturing, sub-contract manufacturing partners and support internal projects.
* Responsible for the company's Quality Management System (QMS) performance reporting to Senior Management Team
* Supervision of Quality Technicians and Engineers. Lead personnel in departmental activities including objectives/goals.
* Quality oversight: management reviews, quality review, and internal audit programme
* Supplier control: supplier audits, SCARs, performance monitoring, and quality agreements
* Manufacturing validation: MVP development, PFMEAs, validation protocols, and reports
* Customer complaints: approval of analysis reports and complaint trends analysis
* CAPA/NCR oversight: timely investigation and closure of CAPA and NCRs
* Lot release: routine sterilization and lot release
* External audits: lead the company in regulatory agency quality management system audits including FDA and Notified Body
* Operations support: provide QA support to Operations meeting their objectives of quality, cost, and output
Requirements:
* Bachelor's degree in scientific discipline required with 4 years experience in medical device/pharmaceutical industry; strong analytical skills, excellent writing, and interpersonal relationship skills or combination of relevant work experience and education
* Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements
* Ability to work as part of team and meet targets/goals efficiently
* Demonstrated organizational, management, and communication skills
* Good interpersonal & communication skills essential
* Strong knowledge of quality principles and ability to utilize these methods in development/manufacturing environments