HireDiversity

Leeds, GB

QC Team Leader-000009VN

Description

DePuy International, a Johnson & Johnson company provides for the treatment of the musculoskeletal system with products that include joint implants, trauma devices and biologic products.

Responsibilities

Essential Functions:

- Manage the activities of a defined team of QC personnel. Management responsibilities to include day to day work allocation and prioritisation, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties
- Responsible for recruitment, development and training of all QC personnel.
- Work closely with other areas of Quality and the business to promote compliance
- Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and material. Manage QA related change control for specific projects as directed.
- Lead Master Validation Planning activities
- Develop and utilise DFMEA/PFMEA and other QC risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Be responsible for the introduction and correct use of statistical QC methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
- Ensure compliance with all Documented Quality system, FDA QSR's and ISO 13485/9001 requirements during day to day and assigned audit/CAPA activities
- Monitor and establish reject and rework rates as directed. Report on these issues, and identify trends and appropriate corrective actions.
- Administration/implementation of Traceability for C of C documentation, DHR systems
- Implement and maintain SOPs to ensure total compliance in areas of responsibility.
- Administer Final Product Sterilisation Release and manage document archives of all related documentation
- Produce and maintain appropriate and comprehensive quality process specifications as required.
- Document and maintain in good order all relevant Quality assurance sections of Device Development History File and DMR as directed by Document Control
- Ensure adherence to HS&E activity and training for all reports to include a good level of housekeeping with all reports involved

Qualifications


Experience

Skills and Abilities (Can Do Criteria):

- Proven staff supervisory capabilities and project management experience
- Degree level qualification or equivalent in an Engineering or Science based discipline
- Alternatively - 5 years experience in a quality role within a regulated industry with a minimum of 2 years experience in a managerial position may be considered in lieu of the academic qualification
- Must have an engineering background in manufacturing with proven ability to interpret engineering specifications and procedures
- Audit experience would be an advantage.
- Must be PC literate and familiar MRP/JDE business software solutions
- High degree of computer literacy
- Highly numerate, with good verbal reasoning skills
- Good negotiating skills
- Excellent planning and organisational abilities
- Good understanding of design and manufacturing principles
- Experience of corporate, ISO and FDA assessments

Personal Traits (Will Do Criteria):

- Well developed organisational skills with ability to work on own initiative
- Good people skills in order to develop excellent staff relations
- Determined approach to problem solving and ability to make decisions concerning product status and disposition
- Good tactical planning ability
- Excellent communication skills and ability to influence where applicable
- Ability to deal with a flexible workload and type is essential
- Excellent organisational skills, with ability to work on own initiative. Good communication and presentation skills in order to effectively communicate technical and QA requirements to all functional departments and external facilities.
- Determined approach to problem solving, and ability to make appropriate decisions concerning product/process disposition and general Quality assurance procedural suitability.
- Ability to deal with flexible workload and type is essential, and also an ability to work productively within a project focused team environment.
Self-motivated and self-disciplined, must be able to work unsupervised and equally well as part of a team

Primary Location:Europe/Middle East/Africa-United Kingdom-England-Leeds
Organization: DePuy Synthes, LLC (6149)
Job Function: Quality Assurance