Quality Engineer II (1 of 4) Job
Company Name:
Depuy Orthopaedics. Inc. (6029)
Horseheads, NY, US
Quality Engineer II (1 of 4
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Engineer II (1 of 4) in Elmira, NY.
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 Quality Engineer II will develop, implement and maintain Quality System requirements on assigned areas of Manufacturing, Process Validation and New Products Introduction. This individuals responsibility may include: Non-conforming product, CAPA, Calibration Systems, Sterility, Measuring techniques, Design of tools and gages, Training, Statistical Support, Quality Planning, Experimental Protocols, Facilitation of Root Cause analysis, Risk Assessment and Complaint Investigation.
The Quality Engineer II will be required to know and follow all laws and policies that apply to one's job and maintain the highest levels of professionalism, ethics and compliance at all times. He/she will diligently participate in our compliance program- related activities as denoted by your supervisor or our Chief Compliance Officer.
The Quality Engineer II will be a member of the Material Review Board (MRB). He/she will communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions. This individual will work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams. The Quality Engineer II will provide quality reports and review trending on assigned areas of responsibility. He/she will conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs). This individual will review and approve documents and drawings for manufacturing and product development (DCOs, MCs). The Quality Engineer II will support Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of new and existing products. He/she will develop training course materials and conduct training for approved documentation and practices.
The Quality Engineer II will participate on cross- functional project teams. He/she will design gauging and develop tools and techniques to measure pertinent product parameters to assure product complies with engineering drawings. This individual will recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities. The Quality Engineer II will develop and document Quality Plans to support new products. He/she will facilitate creation of PFMEA's. This individual will ensure compliance issues are addressed for new product and sustaining activities. The Quality Engineer II will participate on design reviews and risk analysis for new products.
The Quality Engineer II will provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness. He/she will review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval. This individual will provide guidance to others for the generation of clear, concise and defendable protocols and reports. The Quality Engineer II will assist in determination of the need for validation.
Qualifications
A minimum of a Bachelors Degree is required. A Bachelors Degree in Mechanical/Chemical Engineering or related technical field is preferred. A minimum of two years experience in a GMP and/or ISO regulated environment is required. Prior experience in the medical and/or pharmaceutical field is preferred. Prior validation protocol experience (IQ/OQ and PQ) is required. Previous risk management experience is required. Knowledge of FDA's QSR and ISO regulations required. Working knowledge of Geometric Dimensioning and Tolerance, Blueprint Reading, Basic Metrology, Gage Design, Design/Process FMEA and Quality Plan Development are preferred. Strong Statistical ability is required. Experience, including Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments is preferred. Knowledge of Manufacturing Clean Rooms, ISO Class 7 and ISO Class 8 (Class 100,000 and 10,000) is preferred. Environmental monitoring knowledge for Clean Rooms is preferred. Experience with Biomaterials, metallic, ceramic and polymic medical devices is preferred. Knowledge of sterile packaging and sterilization validations is preferred. The ability to work independently with minimum supervision for application of QE principles and Techniques is required. ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification is preferred. Excellent interpersonal and communication skills are required. Working knowledge of Word Processing and Spreadsheet software required (MS Word and Excel knowledge desired). Knowledge of Manufacturing materials and processes (machining, electropolishing, passivation, anodizaton, etc.) is preferred. Attention to detail and ability to meet deadlines is required. The ability to manage multiple projects/requirements in a fast-paced environment is required. The ability to work effectively in a team environment is required.
This position will be located in Elmira, NY and requires up to 10% travel including potential 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
J2W:BIO
J2W:NSJ
J2W:MZ
J2W:DICE
Primary Location:
North America-United States-New York-Horseheads
Organization:
Depuy Orthopaedics. Inc. (6029)
Travel:
Yes, 10 % of the Time
Job Function:
Quality (Eng)
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
Depuy Orthopaedics. Inc. (6029)
Horseheads, NY, US
Quality Engineer II (1 of 4
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Quality Engineer II (1 of 4) in Elmira, NY.
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 Quality Engineer II will develop, implement and maintain Quality System requirements on assigned areas of Manufacturing, Process Validation and New Products Introduction. This individuals responsibility may include: Non-conforming product, CAPA, Calibration Systems, Sterility, Measuring techniques, Design of tools and gages, Training, Statistical Support, Quality Planning, Experimental Protocols, Facilitation of Root Cause analysis, Risk Assessment and Complaint Investigation.
The Quality Engineer II will be required to know and follow all laws and policies that apply to one's job and maintain the highest levels of professionalism, ethics and compliance at all times. He/she will diligently participate in our compliance program- related activities as denoted by your supervisor or our Chief Compliance Officer.
The Quality Engineer II will be a member of the Material Review Board (MRB). He/she will communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions. This individual will work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams. The Quality Engineer II will provide quality reports and review trending on assigned areas of responsibility. He/she will conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs). This individual will review and approve documents and drawings for manufacturing and product development (DCOs, MCs). The Quality Engineer II will support Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of new and existing products. He/she will develop training course materials and conduct training for approved documentation and practices.
The Quality Engineer II will participate on cross- functional project teams. He/she will design gauging and develop tools and techniques to measure pertinent product parameters to assure product complies with engineering drawings. This individual will recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities. The Quality Engineer II will develop and document Quality Plans to support new products. He/she will facilitate creation of PFMEA's. This individual will ensure compliance issues are addressed for new product and sustaining activities. The Quality Engineer II will participate on design reviews and risk analysis for new products.
The Quality Engineer II will provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness. He/she will review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval. This individual will provide guidance to others for the generation of clear, concise and defendable protocols and reports. The Quality Engineer II will assist in determination of the need for validation.
Qualifications
A minimum of a Bachelors Degree is required. A Bachelors Degree in Mechanical/Chemical Engineering or related technical field is preferred. A minimum of two years experience in a GMP and/or ISO regulated environment is required. Prior experience in the medical and/or pharmaceutical field is preferred. Prior validation protocol experience (IQ/OQ and PQ) is required. Previous risk management experience is required. Knowledge of FDA's QSR and ISO regulations required. Working knowledge of Geometric Dimensioning and Tolerance, Blueprint Reading, Basic Metrology, Gage Design, Design/Process FMEA and Quality Plan Development are preferred. Strong Statistical ability is required. Experience, including Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments is preferred. Knowledge of Manufacturing Clean Rooms, ISO Class 7 and ISO Class 8 (Class 100,000 and 10,000) is preferred. Environmental monitoring knowledge for Clean Rooms is preferred. Experience with Biomaterials, metallic, ceramic and polymic medical devices is preferred. Knowledge of sterile packaging and sterilization validations is preferred. The ability to work independently with minimum supervision for application of QE principles and Techniques is required. ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification is preferred. Excellent interpersonal and communication skills are required. Working knowledge of Word Processing and Spreadsheet software required (MS Word and Excel knowledge desired). Knowledge of Manufacturing materials and processes (machining, electropolishing, passivation, anodizaton, etc.) is preferred. Attention to detail and ability to meet deadlines is required. The ability to manage multiple projects/requirements in a fast-paced environment is required. The ability to work effectively in a team environment is required.
This position will be located in Elmira, NY and requires up to 10% travel including potential 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
J2W:BIO
J2W:NSJ
J2W:MZ
J2W:DICE
Primary Location:
North America-United States-New York-Horseheads
Organization:
Depuy Orthopaedics. Inc. (6029)
Travel:
Yes, 10 % of the Time
Job Function:
Quality (Eng)
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
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