Duties and Responsibilities:

• Champion the overall Quality function of the facility
• Sets compliance objectives and ensures target goals are attained
• Develop, implement and manage processes or practices related to SOP's to ensure regulatory compliance
• Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies
• Produce/review audit reports and conduct follow-up evaluations on corrective/preventative measures that address non-compliance
• Manage, coach, counsel and mentor Quality Assurance and Document Control Team members

Skill Sets:

• 3-5 years experience in a highly regulated industry required
• Bachelor's Degree in Life Science field of study, Engineering or 5-7 years of progressively more responsible experience in a similar leadership role
• Strong technical/medical writing skills and exceptional verbal communication abilities required
• Professional Engineering Certification and/or ASQ Certification, knowledge of FDA Regulations (Medical device) and ISO 13485-2016 is strongly