Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and regulations.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Responsible for driving quality programs, continuous improvement projects, and CAPA investigations and solutions to ensure appropriate measures are implemented to prevent recurrence
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of audits.
Supports the NCMR programs and ensure appropriate disposition of nonconforming parts
Supports all departments to ensure timely root cause identification for process/product deviations; may organize, facilitate and document Material Review Board activities.
Utilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques: experimental design, data analysis, sampling techniques and other traditional QA Engineering activities.
Drives site validation and equipment qualification programs; routinely involved with generation, review and/or approval of IQ, OQ, PQ protocols and reports.
Review device history records and release product
Act as back-up to QA Manager as necessary during their absence.
Other duties as assigned
Bachelor’s or Master’s Degree in Engineering, Science, or technical field. 5+ years of related work experience, working in a regulated environment within the Pharma or Medical Devices industry.
- Continuous improvement experience preferred (6 Sigma, Lean, GreenBelt/Black Belt)
- Lead or Internal Auditor Certification to ISO 13485
- Expertise in CAPA and investigation techniques.
- Auditing experience to 21CFR820, ISO 13485, ISO 14971, MDD, and MDSAP.
- Familiar with IEC 60601 and product specific industry standards
- Experience in project management.
- Demonstrated ability to work effectively and positively with all levels of an organization.
- Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
- Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
- Strong organization skills.
- Office conditions with 10-15% travel required.