Supplier Management Quality Representative
NCBiotech, Cary, NC, United States
Supplier Management Quality Professional reporting to the Director of Quality for HC NAM.
Responsibilities
Implementing requirements for all assigned NAM suppliers
Qualifying suppliers based on set requirements prior to supplier selection
Completing supplier audits
Developing quality metrics, as applicable, for suppliers
Performing annual performance evaluations
Driving supplier corrective actions
Participating in supplier development plans as necessary
Reviewing supplier contracts to ensure proper quality requirements are specified
Driving improvement activities to increase efficiency in the supplier management process while ensuring adherence to requirements
Representing the supplier management process during internal and external audits/inspections
Leads/ participates in cross‑functional teams to drive improvement in and provide feedback for global processes that impact NAM compliance to regulations
Maintains supplier management process compliance with all applicable requirements and regulations
Ability to support up to 40% domestic travel
Qualifications
You have a working knowledge of management system requirements for the medical device industry.
Experience in a matrixed organization.
You have management experience, or experience dealing directly with multiple levels of management.
Experience with supplier management requirements and activities.
You possess excellent communication skills.
Ability to build consensus and gain action within a complex organization.
Experience with audits and supplier corrective actions / CAPA.
Required Skills for Success of This Role
BS in Life Sciences or a technical discipline with a minimum of 5–7 years’ experience in the medical device, biotechnology, or pharmaceutical industry.
Knowledge of FDA Quality System Regulations, Health Canada Regulations, and ISO 9001 standards.
Displays a high level of critical thinking in bringing a successful resolution to high‑impact, complex, and/or cross‑functional problems.
Experience with management and oversight of suppliers.
Proven ability to work independently and in a group.
Lead Auditor certification strongly desired (ISO, QSR).
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long‑term disability insurance
Short‑term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Base Pay Range
$117,770 - $161,931
Equal Employment Opportunity Statement
Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state, or local law.
Export Control
A successful candidate must be able to work with controlled technology in accordance with U.S. export control law. Siemens Healthineers’ policy is to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.
#J-18808-Ljbffr
Responsibilities
Implementing requirements for all assigned NAM suppliers
Qualifying suppliers based on set requirements prior to supplier selection
Completing supplier audits
Developing quality metrics, as applicable, for suppliers
Performing annual performance evaluations
Driving supplier corrective actions
Participating in supplier development plans as necessary
Reviewing supplier contracts to ensure proper quality requirements are specified
Driving improvement activities to increase efficiency in the supplier management process while ensuring adherence to requirements
Representing the supplier management process during internal and external audits/inspections
Leads/ participates in cross‑functional teams to drive improvement in and provide feedback for global processes that impact NAM compliance to regulations
Maintains supplier management process compliance with all applicable requirements and regulations
Ability to support up to 40% domestic travel
Qualifications
You have a working knowledge of management system requirements for the medical device industry.
Experience in a matrixed organization.
You have management experience, or experience dealing directly with multiple levels of management.
Experience with supplier management requirements and activities.
You possess excellent communication skills.
Ability to build consensus and gain action within a complex organization.
Experience with audits and supplier corrective actions / CAPA.
Required Skills for Success of This Role
BS in Life Sciences or a technical discipline with a minimum of 5–7 years’ experience in the medical device, biotechnology, or pharmaceutical industry.
Knowledge of FDA Quality System Regulations, Health Canada Regulations, and ISO 9001 standards.
Displays a high level of critical thinking in bringing a successful resolution to high‑impact, complex, and/or cross‑functional problems.
Experience with management and oversight of suppliers.
Proven ability to work independently and in a group.
Lead Auditor certification strongly desired (ISO, QSR).
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long‑term disability insurance
Short‑term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Base Pay Range
$117,770 - $161,931
Equal Employment Opportunity Statement
Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state, or local law.
Export Control
A successful candidate must be able to work with controlled technology in accordance with U.S. export control law. Siemens Healthineers’ policy is to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.
#J-18808-Ljbffr