Oversees the development, implementation and maintenance of combination product and medical device quality systems and activities. Ensures compliance for ISO requirements applicable to the Quality Management Review (QMR) program. Responsible to generate and review documents used in GMP and ISO compliant processes and for regulatory submissions. Provide oversights of key medical device suppliers, conducts device disposition activities and related supplier audits. Acts as the QA lead for Medical Device regulatory authority and notified body inspections. Leads product investigations and resolves potential product quality issues.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Establish and/or maintain the QA programs, policies, and procedures and ensure 21 CFR part 820, 210-11 and ISO 13485 compliance of clinical trial and commercial material.
- Acts as the primary QA contact for medical device vendors, Qualified Persons, validation, change management and other QA matters.
- Oversees and conducts device audits and ensures implementation of effective CAPAs.
- Maintains current understanding of regulatory agency policies and guidance as it pertains to QA matters and informs management of significant changes.
- Manages or conducts QA review of device history records, design and development records, investigational materials packaging and labeling documentation, and documents submitted to regulatory agencies.
- Acts as the subject matter expert for Quality Assurance during regulatory (FDA, ISO, Notified Body) audits.
- Enhances device quality monitoring, identifying and prioritizing complaint trends.
- Conducts medical device training to colleagues as required.
- Conducts risk assessments, quality plans, FMEA as needed.
- Participation in product life cycle development from concept to commercialization.
REQUIREMENTS:
- BS degree and 8 years of related Quality Assurance experience with Medical Device products.
- Experience with auto injectors, prefilled syringes is required.
- Experience with Quality Management System (ISO 13485), MDSAP (Medical Device Single Audit Program), Medical Device Regulations (21 CFR 820) and applicable regulatory requirements and standards.
- Experience with class II/III medical devices.
- Experience leading regulatory inspections and inspection readiness activities.
- Ability to lead and work with and through others, including CMOs.
- Demonstrated ability to provide technical and/or business solutions to complex problems that include assessment of risks and impact.
- Demonstrated ability to work in multi-disciplinary settings acting as facilitator and coach.
- Strong leadership, team building, organizational, communication and interpersonal skills.
Find one job in US 