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 less CAPAs - 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 evaluations Qualifications Must be resourceful - find ways to deal with barriers to success Must recognize own strengths and weaknesses Able to work through conflicts constructively Able to analyze and solve problems Use logical rational thought to make good decisions quickly Able to Set stretch goals for self and team Show high level of accountability Provide praise and recognition along with constructive criticism and feedback.
Able to be respectfully assertive when necessary Knowledgeable of; FDA Regulations ISO 13485:
2016 Requirements Complaint Handling CAPA Process SPC/Trending Documentation control Auditing Must be a hands on person - willing to dig in as necessary Bachelor's degree or equivalent experience in Engineering 5
years' relevant work experience Highly organized with excellent attention to detail Recommended Skills Assertive Attention To Detail Auditing Coordinating Engineering Food Safety Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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 less CAPAs - 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 evaluations Qualifications Must be resourceful - find ways to deal with barriers to success Must recognize own strengths and weaknesses Able to work through conflicts constructively Able to analyze and solve problems Use logical rational thought to make good decisions quickly Able to Set stretch goals for self and team Show high level of accountability Provide praise and recognition along with constructive criticism and feedback.
Able to be respectfully assertive when necessary Knowledgeable of; FDA Regulations ISO 13485:
2016 Requirements Complaint Handling CAPA Process SPC/Trending Documentation control Auditing Must be a hands on person - willing to dig in as necessary Bachelor's degree or equivalent experience in Engineering 5
years' relevant work experience Highly organized with excellent attention to detail Recommended Skills Assertive Attention To Detail Auditing Coordinating Engineering Food Safety Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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