Associate Manager for Quality Compliance - Corporate - Battery Systems - FDA compliance
Our client, a Fortune 200 company located in Richmond, Virginia, is seeking a highly qualified Quality Compliance Associate Manager to join their Quality Audit & Requirements department.
This FDA regulated manufacturer has current products in the market as well as some new exciting products that have gone through the modified risk application with the FDA. In preparation for new product launches, we are searching for an Experienced Quality Compliance leader with battery-powered or electronic medical device experience.
The successful candidate will be responsible for creating and enhancing quality requirements and standards through independent research and interpretation of other FDA regulated industries and standards. This position will work with multiple business partners to conduct quality system gap assessments to evaluate the ability of their quality systems to conform to established requirements and then assist in the development and tracking of gap remediation plans. In addition to the quality requirements related activities, the incumbent will be required to assist in developing quality infrastructure for areas including clinical operations and e-vapor products. Further areas of participation will include conducting quality management system audits and developing communications for emerging quality risk areas.
Associate Quality Manager responsibilities include:
Associate Quality Manager Specific Skills and Qualifications include:
- Independently planning and conducting research on good manufacturing, good laboratory, and good clinical practices pertinent to medical device FDA regulated industries to support the development of the company's Quality Requirement Manual (AQRM), Quality Management System (QMS) and general quality practices.
- Providing guidance and recommendations to management on Good Manufacturing Practices (GMP) implementation.
- Planning and coordinating gap assessments of existing processes and systems against approved AQRM standards using multi-discipline / multi-functional teams.
- Providing regulatory expertise in development of quality requirements for electronic FDA regulated product devices and components.
- Identifying and escalating internal and external situations which may pose quality/compliance risks that may adversely affect business operations.
- Assisting in developing quality management infrastructure for clinical operations.
- Assisting in the development, implementation and continuous monitoring of objectives, procedures, tracking and trending mechanisms to ensure that management is consistently informed on the status and effectiveness of compliance activities.
- Participating in the development of company-wide quality roll-out and training of new AQRM content through training and/or mentoring to increase the overall organizational capability.
- Leading or participating in programs designated to enhance the quality and compliance of the organization.
- Planning, conducting and reporting the results of internal, supplier, and/or clinical related quality audits to departmental and operational management.
- Maintaining confidentiality of information obtained during audits.
- A Bachelor’s Degree in a Science, Engineering or a related field. Desire an Electrical Engineering degree.
- A minimum of 8 years of relevant experience in FDA regulated quality systems and operations (medical devices and IVD or Diagnostic Devices are best fits).
- Detailed-oriented. Must have strong analytical and organizational skills.
- Strong written, verbal and presentation skills along with demonstrated ability to collaborate with others.
- Ability to tactfully, independently and persuasively provide critical and sensitive feedback to the most senior levels of management.
- Proficiency in Battery Powered, Lithium Ion Batteries or Battery Systems or similar power systems is preferred.
- The ability to perform assignments in an independent and autonomous manner with minimal direct supervision.
- Proficiency with various computer software including Word, Excel, PowerPoint and Outlook.
- Certification in ISO, ASQ CQE or CQM is desirable or ability to obtain an ASQC certification within one year of obtaining this position.
- Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods.
- Ability to travel up to 30% throughout the year (domestic and international).