Available Openings 1
Position Specific InformationNxStage Medical, a Fresenius Company is on a mission to transform renal care. To do that, we continually seek the best-of-the-best to expand and improve our team of dedicated, innovative professionals. If you share our mission and are committed to improving the lives of renal patients, then we invite you to explore our career opportunities
PURPOSE AND SCOPE:
This individual will plan, manage, and provide leadership to support compliance through internal audit and supplier assurance activities at the Lawrence facility and provide support as necessary to other NxStage facilities.The individual will collaborate with all company departments and facilities to support the organization’s regulatory compliance in the areas defined above.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- This position will manage the internal audit and supplier assurance quality activities in Lawrence as well as advise other NxStage facilities in those areas.
- Manage the Corporate Internal Audit Program ensuring compliance with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, Health Canada and Australia’s Therapeutic Goods Administration (TGA) requirements.
- Ensure the internal audit program provides valuable feedback to senior management with regards to the health of the quality system and regulatory compliance.
- Develop and maintain metrics reflecting audit results as well as adherence to the requirements of the audit process.
- Develop and maintain regulatory expertise and knowledge of industry trends. Advise the organization of USA and International matters relating to cGMP, QSR requirements, and other regulatory policies and changes being implemented by regulatory agencies regarding the areas of responsibilities defined in this job description.
·Manage the company’s Supplier Assurance system as well as Supplier Corrective Actions (SCARs). Ensure the Supplier Assurance program is in compliance with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, Health Canada and Australia’s Therapeutic Goods Administration (TGA) requirements.
·Conduct supplier audits to ensure compliance to ISO 9001, ISO 13485, FDA Quality System Regulations, 21 CFR Part 820, as applicable.
·Lead supplier development activities as appropriate to improve quality performance.
·Manage SCAR System to include the creation of SCARs, the review of investigation results, and effective execution and closure. Advise other functions’ resources regarding the SCAR process. Develop metrics to monitor SCAR progress and effectiveness of the SCAR process to report to senior management.
·Responsible for the development of Quality Agreements with Key Suppliers. Ensure compliance requirements are identified in quality agreements with suppliers.
- Lead initiatives ensuring process improvement, continuous improvement, preventative and corrective actions, cost effectiveness of processes, systems, and procedures in the areas of responsibility defined in this job description. Develop metrics to monitor progress and effectiveness of actions taken.
- Lead compliance remediation projects as needed.
- Interface with FDA personnel and Competent Authorities on compliance issues regarding internal audits and supplier assurance.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s Degree required; Advanced Degree preferred
EXPERIENCE AND REQUIRED SKILLS:
·Lead Auditor Certification
·5+ years related Quality Assurance in the Medical Device Industry including both domestic and international exposure. This experience should include managing internal audit and supplier assurance programs.
·2+ years management experience preferably in a regulated environment is desired.
·Detailed regulatory knowledge (FDA/21CFR Parts 803, 806, 820; Medical Device Directive; Canadian Medical Device Regulations, ISO 13485, Australia’s TGA regulation as well as any other applicable regulations)
·Experience interacting with FDA and international bodies regarding compliance matters is desired.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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