Quality Engineer II - Post Market Surveillance (PSI) Job
Company Name:
J&J Family of Companies
Quality Engineer II - Post Market Surveillance (PSI)-0644140725
Description
DePuy Mitek, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II - Post Market Surveillance (PSI), 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 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, more agile and better equipped to meet the needs of 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.
DePuy Mitek offers innovative devices in sports medicine for the treatment of soft tissue injuries.
The Quality Engineer II - PSI's role will perform post-market safety and surveillance activities which require systematic collection, analysis, and evaluation of product safety and performance data, with the intent to detect safety signals and determine whether these signals are issues that warrant further action. He/She will conduct trend analyses, signal detection and product investigations with the focus on early warning of patient safety as well as product quality issues. This role will require a complete understanding of the current risk profile of our products while assessing the overall risk/benefit of the product. Quality Engineer II - PSI will also review and update risk management files for completeness and accuracy. In addition this role may lead or support corrective and preventative actions to address any product issues and facilitate field actions, as needed and may also support other quality system activities such as Complaint Investigations, Internal Audits, and third party inspections.
The Quality Engineer II - PSI will also interface with key business partners including R&D;, Operations, Medical and Marketing to ensure a thorough investigation is completed. Depending upon the nature of the identified safety issue/product quality event, the PSI Quality Engineer II will be the key interface with the Quality & Regulatory Compliance group to ensure all events are escalated in a timely manner and per procedure.
This is a hands-on position that will require a self motivated individual with excellent written and oral communication skills. The ideal candidate for this role will have the ability to collaborate with business partners at all levels with multiple functional groups in an environment that embraces teamwork and risk-based decision making.
Qualifications
A minimum Bachelors Degree is required. A Bachelors Degree in Engineering is preferred. A Master's Degree is a plus. A minimum of 2 years experience working in a quality system framework (ISO 9001 or similar) is required. Medical device/diagnostic/or pharmaceutical industry experience is preferred. Excellent problem solving and decision-making skills are required. Root cause analysis skills are required. Experience with Post Market Surveillance/Safety Surveillance activities is preferred. Previous Design Control experience is preferred. Working knowledge of reading and interpreting product specifications is preferred. Experience with statistics/analytics is preferred. Proficiency with the Microsoft Office Suite is required. Knowledge of process and design excellence tools with Green or Black Belt training are preferred.
This position may require up to 10% domestic travel with potential international travel. This position will be based in Raynham, MA.
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)
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 Supplement
Req ID: 0644140725
Date: Tue, 05 08 2014 00:00:00 GMT
Country: US
State: MA
City: Raynham
Postal Code: 02767
Locale: en_USEstimated Salary: $20 to $28 per hour based on qualifications.
J&J Family of Companies
Quality Engineer II - Post Market Surveillance (PSI)-0644140725
Description
DePuy Mitek, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II - Post Market Surveillance (PSI), 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 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, more agile and better equipped to meet the needs of 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.
DePuy Mitek offers innovative devices in sports medicine for the treatment of soft tissue injuries.
The Quality Engineer II - PSI's role will perform post-market safety and surveillance activities which require systematic collection, analysis, and evaluation of product safety and performance data, with the intent to detect safety signals and determine whether these signals are issues that warrant further action. He/She will conduct trend analyses, signal detection and product investigations with the focus on early warning of patient safety as well as product quality issues. This role will require a complete understanding of the current risk profile of our products while assessing the overall risk/benefit of the product. Quality Engineer II - PSI will also review and update risk management files for completeness and accuracy. In addition this role may lead or support corrective and preventative actions to address any product issues and facilitate field actions, as needed and may also support other quality system activities such as Complaint Investigations, Internal Audits, and third party inspections.
The Quality Engineer II - PSI will also interface with key business partners including R&D;, Operations, Medical and Marketing to ensure a thorough investigation is completed. Depending upon the nature of the identified safety issue/product quality event, the PSI Quality Engineer II will be the key interface with the Quality & Regulatory Compliance group to ensure all events are escalated in a timely manner and per procedure.
This is a hands-on position that will require a self motivated individual with excellent written and oral communication skills. The ideal candidate for this role will have the ability to collaborate with business partners at all levels with multiple functional groups in an environment that embraces teamwork and risk-based decision making.
Qualifications
A minimum Bachelors Degree is required. A Bachelors Degree in Engineering is preferred. A Master's Degree is a plus. A minimum of 2 years experience working in a quality system framework (ISO 9001 or similar) is required. Medical device/diagnostic/or pharmaceutical industry experience is preferred. Excellent problem solving and decision-making skills are required. Root cause analysis skills are required. Experience with Post Market Surveillance/Safety Surveillance activities is preferred. Previous Design Control experience is preferred. Working knowledge of reading and interpreting product specifications is preferred. Experience with statistics/analytics is preferred. Proficiency with the Microsoft Office Suite is required. Knowledge of process and design excellence tools with Green or Black Belt training are preferred.
This position may require up to 10% domestic travel with potential international travel. This position will be based in Raynham, MA.
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)
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 Supplement
Req ID: 0644140725
Date: Tue, 05 08 2014 00:00:00 GMT
Country: US
State: MA
City: Raynham
Postal Code: 02767
Locale: en_USEstimated Salary: $20 to $28 per hour based on qualifications.
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