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Senior Quality Auditor-0147140202
Description
DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Auditor, located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Quality Auditor will be responsible for conducting internal and clinical quality audits to assure compliance with applicable government regulations, industry accepted standards, and company policies and procedures. The role as an internal auditor includes all aspects of quality system functions related to medical devices and as a clinical quality auditor, the entire clinical development process.
The Senior Quality Auditor will conduct internal and clinical quality audits to applicable standards, regulations, and company procedures. He/she will document and effectively communicate results, as well as guide auditees on conducting robust failure investigations, root cause analyses, and developing corrective/ preventive actions and effectiveness monitoring plans. This individual will maintain current knowledge of standards and regulations applicable to DePuy Synthes quality system.
This individual must be able to audit independently and collaborate in team settings in order to provide training and guidance to other auditors and auditees, including QA and Good Manufacturing/Clinical Practice (GMP/GCP) training.
The Senior Quality Auditor will assist in the continuous improvement of the Internal and Clinical Quality Assurance (CQA) programs for DePuy Synthes. He/She will conduct trend analyses, investigate potential compliance issues, and keep management informed of trends and potential risks. This individual will develop strong working relationships with all Quality, Compliance, and Clinical Research/Clinical Operation departments across the franchise to ensure effective implementation of the program deliverables. He/she will be responsible for Inspection Readiness activities and supporting External Audit activities.
Qualifications
A minimum of a Bachelors Degree in Engineering, Chemistry, Biology, Life Sciences or equivalent technical degree is required. A minimum of 4 years auditing experience within the Medical Device and/or Drug industry is required. A minimum of 2 years being experience in Quality/Compliance is required. Clinical Quality experience preferred. Working knowledge of FDA Code of Federal Regulations: 21 CFR Part 820, ISO 13485, Medical Device Directive 93/42/EEC, Knowledge of CFR Title 21 parts 50, 54, 56, 312, 812, ICH GCP guidelines are preferred. Clinical Research process is preferred. External Inspection experience is preferred. Overseas inspection experience is preferred. Excellent verbal and written communication skills are required. Organizational skills providing the ability to multi-task in a fast-paced environment are required. Demonstrated track record in fostering collaboration and building consensus to achieve collective objectives is required.
This position will be located in Raynham, MA and requires up to 30% travel, including international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Internal Audit
Travel:Yes, 25 % of the Time
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Senior Quality Auditor-0147140202
Description
DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Auditor, located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Quality Auditor will be responsible for conducting internal and clinical quality audits to assure compliance with applicable government regulations, industry accepted standards, and company policies and procedures. The role as an internal auditor includes all aspects of quality system functions related to medical devices and as a clinical quality auditor, the entire clinical development process.
The Senior Quality Auditor will conduct internal and clinical quality audits to applicable standards, regulations, and company procedures. He/she will document and effectively communicate results, as well as guide auditees on conducting robust failure investigations, root cause analyses, and developing corrective/ preventive actions and effectiveness monitoring plans. This individual will maintain current knowledge of standards and regulations applicable to DePuy Synthes quality system.
This individual must be able to audit independently and collaborate in team settings in order to provide training and guidance to other auditors and auditees, including QA and Good Manufacturing/Clinical Practice (GMP/GCP) training.
The Senior Quality Auditor will assist in the continuous improvement of the Internal and Clinical Quality Assurance (CQA) programs for DePuy Synthes. He/She will conduct trend analyses, investigate potential compliance issues, and keep management informed of trends and potential risks. This individual will develop strong working relationships with all Quality, Compliance, and Clinical Research/Clinical Operation departments across the franchise to ensure effective implementation of the program deliverables. He/she will be responsible for Inspection Readiness activities and supporting External Audit activities.
Qualifications
A minimum of a Bachelors Degree in Engineering, Chemistry, Biology, Life Sciences or equivalent technical degree is required. A minimum of 4 years auditing experience within the Medical Device and/or Drug industry is required. A minimum of 2 years being experience in Quality/Compliance is required. Clinical Quality experience preferred. Working knowledge of FDA Code of Federal Regulations: 21 CFR Part 820, ISO 13485, Medical Device Directive 93/42/EEC, Knowledge of CFR Title 21 parts 50, 54, 56, 312, 812, ICH GCP guidelines are preferred. Clinical Research process is preferred. External Inspection experience is preferred. Overseas inspection experience is preferred. Excellent verbal and written communication skills are required. Organizational skills providing the ability to multi-task in a fast-paced environment are required. Demonstrated track record in fostering collaboration and building consensus to achieve collective objectives is required.
This position will be located in Raynham, MA and requires up to 30% travel, including international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Internal Audit
Travel:Yes, 25 % of the Time
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.