MQA Manager

Job description

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE:

Responsible for leading a team of Quality professionals and management of applicable Quality System requirements within the QA functional area of responsibility, in accordance with corporate, divisional and applicable regulatory requirements.

​MAIN RESPONSIBILITIES:

·  Prioritise and co-ordinate resources ensuring department and site goals are achieved.
·  Provide effective people leadership to all team members, including goal setting, performance reviews, development planning and performance management.
·  Implement a work environment that ensures all communications, interpersonal interactions and business behaviors are consistent with SH values and the Abbott Code of Conduct.
·  Build and maintain effective cross functional relationships with all areas of the business.
·  Maintain an appropriate balance of quality, compliance and business risk. Provide compliant yet practical solutions that minimise the impact of Quality issues
·  Manage the investigation of non-conformances affecting area of responsibility, and ensure implementation of timely and effective corrective action
·  Present and communicate status, report metrics, identify trends and potential issuesand escalate to management any issues pertaining to non compliance or failure to achieve agree performance targets
·  Represent SH  to internal/external Auditors and Regulatory bodies on any matter relating to area of responsibility. Ensure area of responsibility and processes are audit ready at all times and all audits are supported from a resource and information request perspective
·  Maintain the quality and compliance status of associated procedures, work instructions and training materials.
·  Identify and implement initiatives for continuous improvement of the Quality System.
·  Ensure approaches to Quality and Compliance are consistently applied within the business and across the Division.
·  Ensure effective communication with other staff and Quality Management to share information and support the attainment of Quality goals and business objectives.
·  Provide divisional level support and guidance as SME for area of responsibility.
·  Liaise with the QA Management concerning the recruitment of staff, making sure staffing levels are maintained and recruitment activity is scheduled in line with departmental needs.
·  When requested, accept any responsibilities and perform any necessary tasks to support the business and other QAC activities.
·  Proactively address Health and Safety concerns within the working environment in order to reduce hazards and risk.

​ QUALIFICATIONS:

·  6 year roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.  Industry certification preferred.
·  Class III or II medical device experience.
·  0 - 5 years in a supervisory/leadership role.
·  Ability to travel internationally to support international manufacturing sites.
·  Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
·  Demonstrated and impactful strong project management and people leadership skills required.
·  Experience working in a broader enterprise/cross division business unit model preferred.
·  Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.  
·  Ability to work effectively within a team in a fast-paced changing environment.
·  Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
·  Multi-tasks, prioritizes and meets deadlines in timely manner.
·  Strong organizational, planning, and follow-up skills and ability to hold others accountable.

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

        

LOCATION:

China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable