Quality Assurance SPV
The Quality Assurance (QA) Manager will be responsible for managing the MycoScience Quality Management systems.
The role is responsible for the coordination and implementation of on-site and desk/documentation customer audits of MycoScience and, related observations, Non-Conformances, CAPAs and communication of system results.
Core Competencies and Responsibilities include:
Act as point of contact between MycoScience, and it's customers on key compliance issues.
Participate on Quality Management System (QMS) integration team.
Leading and tracking in Millstone's Mastercontrol electronic QMS as site administrator for MycoScience.
Leading the internal audit program and compliance with regulatory requirements.
Leading the CAPA program (CAPA, Complaints) and compliance with regulatory requirements.
Maintain oversight on the day to day progress of quality issue records.
Leading inter-departmental investigations with applicable departments for assessing and addressing potential quality issues.
Review and approval of equipment and test method validation protocols and reports.
Responsible for managing the Quality Assurance team.
Other quality-related tasks as assigned.
Knowledge & Skills:
Bachelor's Degree 5
years of relevant experience in Quality, Management, Engineering or Microbiology based testing Attention to detail with the ability to recognize and communicate potential issues Advanced math skills - basic statistics Advanced ability to create Excel, PowerPoint and Word documents Ability to write or re-write procedures, forms and master batch records Excellent organizational skills with the ability to provide supervision and leadership Excellent interpersonal skills Knowledge of standards and requirements related to FDA/GMP compliance Knowledge of standards and requirements related to ISO 13485 & 17025 compliance Knowledge of medical device testing specifically microbiology based testing or medical device manufacturing ASQ or RABQSA certification preferred (i.
e.
CQE, CQA, Lead Auditor) ISO 13485 Lead Auditor certification or equivalent preferred ISO 17025 Lead Auditor certification or equivalent preferred Recommended Skills Attention To Detail Auditing Certified Quality Engineer Coordinating Engineering Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
The role is responsible for the coordination and implementation of on-site and desk/documentation customer audits of MycoScience and, related observations, Non-Conformances, CAPAs and communication of system results.
Core Competencies and Responsibilities include:
Act as point of contact between MycoScience, and it's customers on key compliance issues.
Participate on Quality Management System (QMS) integration team.
Leading and tracking in Millstone's Mastercontrol electronic QMS as site administrator for MycoScience.
Leading the internal audit program and compliance with regulatory requirements.
Leading the CAPA program (CAPA, Complaints) and compliance with regulatory requirements.
Maintain oversight on the day to day progress of quality issue records.
Leading inter-departmental investigations with applicable departments for assessing and addressing potential quality issues.
Review and approval of equipment and test method validation protocols and reports.
Responsible for managing the Quality Assurance team.
Other quality-related tasks as assigned.
Knowledge & Skills:
Bachelor's Degree 5
years of relevant experience in Quality, Management, Engineering or Microbiology based testing Attention to detail with the ability to recognize and communicate potential issues Advanced math skills - basic statistics Advanced ability to create Excel, PowerPoint and Word documents Ability to write or re-write procedures, forms and master batch records Excellent organizational skills with the ability to provide supervision and leadership Excellent interpersonal skills Knowledge of standards and requirements related to FDA/GMP compliance Knowledge of standards and requirements related to ISO 13485 & 17025 compliance Knowledge of medical device testing specifically microbiology based testing or medical device manufacturing ASQ or RABQSA certification preferred (i.
e.
CQE, CQA, Lead Auditor) ISO 13485 Lead Auditor certification or equivalent preferred ISO 17025 Lead Auditor certification or equivalent preferred Recommended Skills Attention To Detail Auditing Certified Quality Engineer Coordinating Engineering Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
