Quality Assurance and Regulatory Compliance Manager

Company DescriptionCommand Medical products is a growing, dynamic medical device contract manufacturer with facilities in FL and Nicaragua. Recently acquired by Argosy Healthcare Partners as a platform company. Our goal is to diversify our capabilities and expand our customer base while continuing to provide value to our customers, stakeholders and employees while being good community stewards. Responsibilities include:Internal Quality Issue - disposition within 3 days for 90% of the issues & identify root cause and preventative action within 30 days.Complaint Handling - acknowledge within 24 hours and close 95% of them in 30 days or lessCAPAs - close 95% within 60 days.Inspect all material received to the proper levels within 3 days of receipt.Utilize SPC/Trending within incoming inspection and production to prevent potential issues within production.Plan and effectively execute internal audits to ensure compliance to the Quality System.Act as Management Representative for all FDA, ISO and Customer audits with a goal of zero(0) major findings.Build a strong team through coaching, mentoring, specific training and performance evaluationsQualificationsMust be resourceful - find ways to deal with barriers to successMust recognize own strengths and weaknessesAble to work through conflicts constructivelyAble to analyze and solve problemsUse logical rational thought to make good decisions quicklyAble to Set stretch goals for self and teamShow high level of accountabilityProvide praise and recognition along with constructive criticism and feedback.Able to be respectfully assertive when necessaryKnowledgeable of;     FDA Regulations     ISO 13485:2016 Requirements     Complaint Handling     CAPA Process     SPC/Trending     Documentation control     AuditingMust be a hands on person - willing to dig in as necessaryBachelor's degree or equivalent experience in Engineering5+ years' relevant work experienceHighly organized with excellent attention to detail