Sr. Compliance & Quality Systems Specialist Job
Company Name:
Lifescan Inc. (6097)
Wayne, PA, US
Sr. Compliance & Quality Systems Specialist
Description
LifeScan, Inc., a member of Johnson & Johnson Family of Companies, is recruiting for a Sr. Compliance & Quality Systems Specialist in Wayne, PA.
LifeScan is the leading manufacturer of blood glucose monitoring systems in the U.S. More than 5 million people depend on the company's OneTouch Brand Products for simple testing and accurate results to help them manage their diabetes. In addition, OneTouch products are recommended by more Healthcare Professionals than any other brand. Consisting of a portable electronic meter and disposable reagent test strips, our systems provide results in just 5 seconds and include tools to help transform results into actionable health care decisions. To learn more visit . Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Sr. Compliance & Quality Systems Specialist will lead metrics program and partner with Franchise and J&J Enterprise/Sector to align metrics into the corporate
database(s) like Metrics Studio. Send periodic updates to action owners and drive closure by partnering with owners and quality approvers. Support Internal Audit Program including performance of assigned audits. Support Quality Review Boards and/or Field Action activities as a team member or facilitator. Support Compliance/Quality Systems improvement initiatives.
The Sr. Compliance & Quality Systems Specialist will also provide guidance to functional organizations and project teams across the Diabetes Care Franchise on the interpretation and application of regulations and standards. May assist in the development of new procedures or revisions to existing procedures including release in the document management system.
Qualifications
To be considered for the role a minimum of a Bachelor's Degree is required, preferably in Engineering or Sciences. Five or more years of related experience in Quality Assurance, Quality Systems, and/or Compliance in Medical Devices, Pharmaceutical or regulated healthcare industries is required. Extensive knowledge of FDA Quality System Regulations, ISO 13485 Standard and International regulations are required. Ability to effectively translate regulations and standards into defined requirements. Excellent written and verbal communication skills. This position will be located in Wayne, PA and will require the ability to travel up to 30%, both domestic and internationally.
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
Primary Location:
North America-United States-Pennsylvania-Wayne
Organization:
Lifescan Inc. (6097)
Travel:
Yes, 25 % of the Time
Job Function:
Compliance
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.
Lifescan Inc. (6097)
Wayne, PA, US
Sr. Compliance & Quality Systems Specialist
Description
LifeScan, Inc., a member of Johnson & Johnson Family of Companies, is recruiting for a Sr. Compliance & Quality Systems Specialist in Wayne, PA.
LifeScan is the leading manufacturer of blood glucose monitoring systems in the U.S. More than 5 million people depend on the company's OneTouch Brand Products for simple testing and accurate results to help them manage their diabetes. In addition, OneTouch products are recommended by more Healthcare Professionals than any other brand. Consisting of a portable electronic meter and disposable reagent test strips, our systems provide results in just 5 seconds and include tools to help transform results into actionable health care decisions. To learn more visit . Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Sr. Compliance & Quality Systems Specialist will lead metrics program and partner with Franchise and J&J Enterprise/Sector to align metrics into the corporate
database(s) like Metrics Studio. Send periodic updates to action owners and drive closure by partnering with owners and quality approvers. Support Internal Audit Program including performance of assigned audits. Support Quality Review Boards and/or Field Action activities as a team member or facilitator. Support Compliance/Quality Systems improvement initiatives.
The Sr. Compliance & Quality Systems Specialist will also provide guidance to functional organizations and project teams across the Diabetes Care Franchise on the interpretation and application of regulations and standards. May assist in the development of new procedures or revisions to existing procedures including release in the document management system.
Qualifications
To be considered for the role a minimum of a Bachelor's Degree is required, preferably in Engineering or Sciences. Five or more years of related experience in Quality Assurance, Quality Systems, and/or Compliance in Medical Devices, Pharmaceutical or regulated healthcare industries is required. Extensive knowledge of FDA Quality System Regulations, ISO 13485 Standard and International regulations are required. Ability to effectively translate regulations and standards into defined requirements. Excellent written and verbal communication skills. This position will be located in Wayne, PA and will require the ability to travel up to 30%, both domestic and internationally.
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
Primary Location:
North America-United States-Pennsylvania-Wayne
Organization:
Lifescan Inc. (6097)
Travel:
Yes, 25 % of the Time
Job Function:
Compliance
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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