Quality Engineering Team Leader-00000LO7
Description
DePuy has been a pioneer in the fields of orthopaedics, spinal care and neuroscience therapies for decades.
From non-surgical pain management to complete surgical solutions, it’s range of treatment options include those for treating or reconstructing damaged or diseased joints, caring for traumatic skeletal injuries, treating spinal disorders and deformity, and repairing injured soft tissue. In addition, DePuy offers a wide range of state-of-the-art therapies for neurological and central nervous system care.
DePuy CMW at Blackpool specialises in the manufacture of bone cement and related chemical products supplied to a global market, primarily for joint replacement surgery.
A member of the Johnson & Johnson Family of Companies, the world’s leading healthcare company, DePuy is dedicated to providing patients all around the globe with a lifetime of movement solutions.
What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your leadership experience; express your passion and touch the world.
We have a great opportunity for a Quality Engineering Team Leader who will Lead the quality activities for all product and process validation activities for all DePuy CMW.
Duties & Responsibilities (leadership, people development, planning and execution)
Develop and maintain state of the art protocols and procedures and ensure correct implementation across site.
Provide technical expertise for all areas on relevant IQ/OQ/PQ protocol issues. Maintain and lead the Site validation master plan
Lead site wide activities aimed at maintaining Part 11 Compliance.
Lead Quality Engineering effort for all manufacturing processes. This will include managing projects designed to identify and implement process improvements within the area.
Provide the Quality effort for all New Product Development activities to ensure that all Quality aspects of process design are addressed.
Document and maintain in good order all relevant sections of Device Design History File and DMR as directed.
Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
Work with Production and Technical Support to develop and implement appropriate process control plans.
Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated products and components are compliant.
Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated design changes managed and documented in a compliant manner.
Ensure compliance with all Documented Quality system, FDA QSR's and ISO 13485 requirements during day to day and assigned audit/CAPA activities.
Maintain a good level of housekeeping in designated areas, and observe all Health and Safety at work requirements.
Operate within the company's standard procedures where applicable, and review, maintain and create appropriate procedures for sphere of activity.
Qualifications
QUALIFICATIONS/EXPERIENCE
Industry relevant experience in a science based discipline or experience in a quality related role.
Demonstrable high level knowledge of product and process validation including Part 11.
Sound knowledge of cGMP and regulatory standards. Must be experienced with working within a regulated environment; a working knowledge of ISO9001, ISO13485 and / or FDA
Quality System Regulations would be an advantage.
Ideal candidate will be a Black belt or have experience in the use of SPC techniques, Gage R&R, First Article Inspection etc.
Ideal candidate will have a polymer processing or chemical engineering background with a proven ability to interpret and create specifications and procedures.
Knowledge of the medical device (or closely-related, healthcare, etc) industry.
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Blackpool
Organization: Depuy Int'l Ltd. (8722)
Job Function: Quality (Eng)
Description
DePuy has been a pioneer in the fields of orthopaedics, spinal care and neuroscience therapies for decades.
From non-surgical pain management to complete surgical solutions, it’s range of treatment options include those for treating or reconstructing damaged or diseased joints, caring for traumatic skeletal injuries, treating spinal disorders and deformity, and repairing injured soft tissue. In addition, DePuy offers a wide range of state-of-the-art therapies for neurological and central nervous system care.
DePuy CMW at Blackpool specialises in the manufacture of bone cement and related chemical products supplied to a global market, primarily for joint replacement surgery.
A member of the Johnson & Johnson Family of Companies, the world’s leading healthcare company, DePuy is dedicated to providing patients all around the globe with a lifetime of movement solutions.
What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your leadership experience; express your passion and touch the world.
We have a great opportunity for a Quality Engineering Team Leader who will Lead the quality activities for all product and process validation activities for all DePuy CMW.
Duties & Responsibilities (leadership, people development, planning and execution)
Develop and maintain state of the art protocols and procedures and ensure correct implementation across site.
Provide technical expertise for all areas on relevant IQ/OQ/PQ protocol issues. Maintain and lead the Site validation master plan
Lead site wide activities aimed at maintaining Part 11 Compliance.
Lead Quality Engineering effort for all manufacturing processes. This will include managing projects designed to identify and implement process improvements within the area.
Provide the Quality effort for all New Product Development activities to ensure that all Quality aspects of process design are addressed.
Document and maintain in good order all relevant sections of Device Design History File and DMR as directed.
Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
Work with Production and Technical Support to develop and implement appropriate process control plans.
Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated products and components are compliant.
Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated design changes managed and documented in a compliant manner.
Ensure compliance with all Documented Quality system, FDA QSR's and ISO 13485 requirements during day to day and assigned audit/CAPA activities.
Maintain a good level of housekeeping in designated areas, and observe all Health and Safety at work requirements.
Operate within the company's standard procedures where applicable, and review, maintain and create appropriate procedures for sphere of activity.
Qualifications
QUALIFICATIONS/EXPERIENCE
Industry relevant experience in a science based discipline or experience in a quality related role.
Demonstrable high level knowledge of product and process validation including Part 11.
Sound knowledge of cGMP and regulatory standards. Must be experienced with working within a regulated environment; a working knowledge of ISO9001, ISO13485 and / or FDA
Quality System Regulations would be an advantage.
Ideal candidate will be a Black belt or have experience in the use of SPC techniques, Gage R&R, First Article Inspection etc.
Ideal candidate will have a polymer processing or chemical engineering background with a proven ability to interpret and create specifications and procedures.
Knowledge of the medical device (or closely-related, healthcare, etc) industry.
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Blackpool
Organization: Depuy Int'l Ltd. (8722)
Job Function: Quality (Eng)