The Director of Quality Assurance directs and coordinates all quality assurance activities within an FDA regulated design and manufacturing plant, including managing a quality assurance team working under ISO 13485. All candidates should have progressive leadership experience with developing quality systems, audit, and IQ, OQ PQ, process validation. Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and ISO 13485, ISO 149712 and 21CFR and other worldwide regulations.