SHL Medical
Position:
QMS Manager
at
SHL Medical
Location: Charleston, South Carolina, US
Job Overview Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction. Provides leadership that results in the implementation and achievement of the quality policy and functional objectives including initiatives in conjunction with the Associate Director of Quality.
Main Responsibilities
Implement and maintain Charleston site Quality Management System in accordance with ISO 13485 and FDA regulations.
Establish and maintain training system. Provide training, as appropriate.
Coordinate, compile and present Site Management Review. Responsible for trending/analysis of KPI data based on SOPs for recording, evaluation and reporting of quality and reliability data.
Plan, coordinate, and conduct scheduled internal audits to assess compliance with FDA, ISO, other applicable standard requirements, and internal requirements.
Maintain and monitor change control process. Own and process change control records, as appropriate.
Represent Charleston site in global conferences and meetings related to the site quality management system.
Responsible for the implementation, coordination, and review of the CAPA system. Facilitate CAPA management in other areas of the organization.
Lead and coordinate external audit preparation, execution, and closure activities for each audit. Interface directly with Quality Management System Process and Sub-Process owners, SMEs, and Global Quality Systems personnel, as needed.
Provide front and/or backroom audit support.
Oversee Material Review Board (MRB) and the investigation process.
Coordinate root cause analysis training.
Oversee batch release process and coordinate product release.
Maintain supplier qualifications and overall maintenance of supplier quality process.
Work with Quality and other leaders to identify areas within the quality management system that need improvement and manage Corrective and Preventive Actions, as appropriate.
Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to the position responsibilities.
Perform additional tasks as needed for the support production systems (MES, SAP).
Lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports.
Skills and Qualifications
Bachelor’s degree in Life Science or equivalent.
Minimum of 8+ years’ experience in Quality Management Systems or medical device field.
Demonstrated leadership and people management experience within a functional management role.
Comprehensive understanding of the QSR, cGMP and ISO/MDD standards.
Excellent communication skills with the ability to influence others.
High level of initiative & autonomy through continuous questioning of current practices.
Fluent in English.
Effective team member, motivated to achieve and demonstrate best practices in line with the department and global objectives.
We Offer
Competitive compensation package
Modern working environment with state-of-the-art facilities and technologies
Challenging assignments in a fast growing and innovative industry
Position in a dynamic, international team of highly skilled professionals
Various opportunities for personal and professional development within a global organization
This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check. SHL is a drug‑free employer.
For more information on SHL Medical, please visit: shl‑medical.com
#J-18808-Ljbffr
QMS Manager
at
SHL Medical
Location: Charleston, South Carolina, US
Job Overview Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction. Provides leadership that results in the implementation and achievement of the quality policy and functional objectives including initiatives in conjunction with the Associate Director of Quality.
Main Responsibilities
Implement and maintain Charleston site Quality Management System in accordance with ISO 13485 and FDA regulations.
Establish and maintain training system. Provide training, as appropriate.
Coordinate, compile and present Site Management Review. Responsible for trending/analysis of KPI data based on SOPs for recording, evaluation and reporting of quality and reliability data.
Plan, coordinate, and conduct scheduled internal audits to assess compliance with FDA, ISO, other applicable standard requirements, and internal requirements.
Maintain and monitor change control process. Own and process change control records, as appropriate.
Represent Charleston site in global conferences and meetings related to the site quality management system.
Responsible for the implementation, coordination, and review of the CAPA system. Facilitate CAPA management in other areas of the organization.
Lead and coordinate external audit preparation, execution, and closure activities for each audit. Interface directly with Quality Management System Process and Sub-Process owners, SMEs, and Global Quality Systems personnel, as needed.
Provide front and/or backroom audit support.
Oversee Material Review Board (MRB) and the investigation process.
Coordinate root cause analysis training.
Oversee batch release process and coordinate product release.
Maintain supplier qualifications and overall maintenance of supplier quality process.
Work with Quality and other leaders to identify areas within the quality management system that need improvement and manage Corrective and Preventive Actions, as appropriate.
Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to the position responsibilities.
Perform additional tasks as needed for the support production systems (MES, SAP).
Lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports.
Skills and Qualifications
Bachelor’s degree in Life Science or equivalent.
Minimum of 8+ years’ experience in Quality Management Systems or medical device field.
Demonstrated leadership and people management experience within a functional management role.
Comprehensive understanding of the QSR, cGMP and ISO/MDD standards.
Excellent communication skills with the ability to influence others.
High level of initiative & autonomy through continuous questioning of current practices.
Fluent in English.
Effective team member, motivated to achieve and demonstrate best practices in line with the department and global objectives.
We Offer
Competitive compensation package
Modern working environment with state-of-the-art facilities and technologies
Challenging assignments in a fast growing and innovative industry
Position in a dynamic, international team of highly skilled professionals
Various opportunities for personal and professional development within a global organization
This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check. SHL is a drug‑free employer.
For more information on SHL Medical, please visit: shl‑medical.com
#J-18808-Ljbffr