Senior Supplier Quality Assurance Manager-00000O5E
Description
- Provide Quality Leadership in support of External Manufacturing Outsourcing programs
- Work at select Preferred Supplier, non-preferred suppliers and EM locations to –
Produce advanced quality planning documentation
Conduct Process Capability Studies,
Develop and implement efficient and effective inspection points and control plans at the supplier in line with J&J MDD Standards.
- Manage the DePuy Suzhou supplier audit management schedule
- Drive a standardised approach by co-ordinating the Supplier Management Committee meetings at DePuy Suzhou
- Maintain and control the list of approved suppliers for the DePuy Suzhou
- Maintain and control company SOPs in support of initial supplier approval and continuous supplier evaluation
- Maintain supplier management documentation and records to ensure they are complete and current
- Promote continuous improvement and Process Excellence activities within the DePuy franchise WW Supplier Quality group
- Deploy and Support the J&J MD&D SQ/EM standards and Initiates
- Work with GSC Procurement Group and Suzhou R&D group to ensure supplier engineering resources are prioritised in support of International business and quality aims
- In support of external assessments of DePuy International facilities, ensure all supplier engineering data to aid preparation is provided in advance and all supplier engineering procedures are deployed effectively
- Develop supplier capability in risk assessment such as PFMEA,
- Actively drive all defined External Manufacturing Quality Systems goals and objectives.
- Represent Quality at commodity team Supplier Business Review Meetings
- Conduct on-site quality, HSE and process assessments at preferred, non-preferred and EM suppliers both to approve new suppliers and on an ongoing basis, as appropriate in the International region
- Review and approve Validation of new/changed production processes as required
- Ensure suppliers continue to meet DePuy Quality requirements with regard to SEP-619 compliance
- Participate in design evaluations where appropriate
- Resolve problems & eliminate constraints to ensure project and supply targets are met.
- Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance
- Ensure effective and timely closure on all Supplier Corrective Action Requests.
- Maintain standards of housekeeping & GMP requirements
- Represent the Supply Process Quality Assurance function as required by management
- Ensure that all Health, Safety and Environmental requirements are fulfilled.
- Maintain detailed and accurate records of all activities
Qualifications
￭ Excellent Communication Skills, written and verbal
￭ Pro-active approach to work with hands on ability
￭ Ability to interpret, communicate, and work from drawings and specifications
￭ Team Player / team building capabilities
￭ Flexible in working practices and approach
￭ Influencing and negotiating skills
￭ High level of validation knowledge
￭ Highly computer literate
￭ High level of GMP knowledge
￭ Excellent project management skills
￭ High attention to detail
￭ High work standards, well organised and meticulous
￭ Excellent planning and organisation skills
￭ Highly numerate, with good verbal reasoning skills
￭ Excellent understanding and appreciation of commercial business systems
￭ Good understanding of design, engineering and manufacturing principles
￭ Customer focused
￭ People Management Skills
￭ Demonstrating Training and Coaching Skills
ESSENTIAL:
￭ Degree level qualification or equivalent in an engineering or science based discipline
￭ Minimum 5 years experience in a senior Quality or Engineering Function within the Medical Device or other similarly regulated industry.
￭ Experienced in SPC, Advanced Quality Planning, Product Validation and ISO 13485.
￭ Knowledge of applicable production processes
￭ Previous experience of product transfers/star up
￭ Willingness to travel up to 40%
DESIRABLE:
￭ Process Excellence – Green/Black belt certification
￭ Previous People management experience
￭ Project management experience.
￭ Knowledge of Orthopaedic products and manufacturing processes
￭ ISO 13485 and QSR (or related sector specific standard) lead assessor qualification
Primary Location:Asia Pacific-China-Jiangsu-Suzhou
Organization: Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function: Quality Assurance
Description
- Provide Quality Leadership in support of External Manufacturing Outsourcing programs
- Work at select Preferred Supplier, non-preferred suppliers and EM locations to –
Produce advanced quality planning documentation
Conduct Process Capability Studies,
Develop and implement efficient and effective inspection points and control plans at the supplier in line with J&J MDD Standards.
- Manage the DePuy Suzhou supplier audit management schedule
- Drive a standardised approach by co-ordinating the Supplier Management Committee meetings at DePuy Suzhou
- Maintain and control the list of approved suppliers for the DePuy Suzhou
- Maintain and control company SOPs in support of initial supplier approval and continuous supplier evaluation
- Maintain supplier management documentation and records to ensure they are complete and current
- Promote continuous improvement and Process Excellence activities within the DePuy franchise WW Supplier Quality group
- Deploy and Support the J&J MD&D SQ/EM standards and Initiates
- Work with GSC Procurement Group and Suzhou R&D group to ensure supplier engineering resources are prioritised in support of International business and quality aims
- In support of external assessments of DePuy International facilities, ensure all supplier engineering data to aid preparation is provided in advance and all supplier engineering procedures are deployed effectively
- Develop supplier capability in risk assessment such as PFMEA,
- Actively drive all defined External Manufacturing Quality Systems goals and objectives.
- Represent Quality at commodity team Supplier Business Review Meetings
- Conduct on-site quality, HSE and process assessments at preferred, non-preferred and EM suppliers both to approve new suppliers and on an ongoing basis, as appropriate in the International region
- Review and approve Validation of new/changed production processes as required
- Ensure suppliers continue to meet DePuy Quality requirements with regard to SEP-619 compliance
- Participate in design evaluations where appropriate
- Resolve problems & eliminate constraints to ensure project and supply targets are met.
- Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance
- Ensure effective and timely closure on all Supplier Corrective Action Requests.
- Maintain standards of housekeeping & GMP requirements
- Represent the Supply Process Quality Assurance function as required by management
- Ensure that all Health, Safety and Environmental requirements are fulfilled.
- Maintain detailed and accurate records of all activities
Qualifications
￭ Excellent Communication Skills, written and verbal
￭ Pro-active approach to work with hands on ability
￭ Ability to interpret, communicate, and work from drawings and specifications
￭ Team Player / team building capabilities
￭ Flexible in working practices and approach
￭ Influencing and negotiating skills
￭ High level of validation knowledge
￭ Highly computer literate
￭ High level of GMP knowledge
￭ Excellent project management skills
￭ High attention to detail
￭ High work standards, well organised and meticulous
￭ Excellent planning and organisation skills
￭ Highly numerate, with good verbal reasoning skills
￭ Excellent understanding and appreciation of commercial business systems
￭ Good understanding of design, engineering and manufacturing principles
￭ Customer focused
￭ People Management Skills
￭ Demonstrating Training and Coaching Skills
ESSENTIAL:
￭ Degree level qualification or equivalent in an engineering or science based discipline
￭ Minimum 5 years experience in a senior Quality or Engineering Function within the Medical Device or other similarly regulated industry.
￭ Experienced in SPC, Advanced Quality Planning, Product Validation and ISO 13485.
￭ Knowledge of applicable production processes
￭ Previous experience of product transfers/star up
￭ Willingness to travel up to 40%
DESIRABLE:
￭ Process Excellence – Green/Black belt certification
￭ Previous People management experience
￭ Project management experience.
￭ Knowledge of Orthopaedic products and manufacturing processes
￭ ISO 13485 and QSR (or related sector specific standard) lead assessor qualification
Primary Location:Asia Pacific-China-Jiangsu-Suzhou
Organization: Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function: Quality Assurance