Responsible for implementation and maintenance of all aspects of quality system including complaints, CAPA, internal audits and document control.
- Provide guidance and leadership and manages complaint handling function to ensure complaint rate and response times per goals. Responsible for monthly complaints meetings.
- Prepare for and conduct management review, monthly and quarterly complaint meetings.
- Manage Complaints, CAPA, Internal Audit and Document Control functions to meet business needs with effective compliance.
- Support electronic document control system and electronic complaints management system acting as an expert and. Implement improvements in those systems and take responsibility for verification/validation of such systems.
- Provide support for design control process (e.g., verification and validation activities, risk analysis, etc.) for assigned product line(s).
- Provide support for manufacturing to improve yields, compliance and effectiveness of inspection and test functions.
- Participate in new product development and sustaining engineering projects as needed.
- Identify improvement opportunities, recommend improvements and implement changes to quality system including inspection and testing methodologies.
- Leads cross functional team to investigate CAPA and complaints. Perform root cause analysis.
- Perform internal audits as needed.
- Assist with preparing Technical Files and other regulatory submissions.
- Manage internal audits process to ensure thorough and timely audits.
- Manage the incoming quality control function to assure the flow of components for manufacturing.
- Manage the corrective and preventive action activities to remediate non-conformances, and improve the Zoll Quality System and products.
- Lead FDA and other regulatory agency audits.
- Perform supplier audits with help of assigned ZOLL team.Interface with European Notified Body on ISO 13485/CE Mark matters.
- Occasional travel to other ZOLL locations and suppliers may be required.
- Minimum of 7 years related experience in a supervisory or managerial role
- Project management experience
- Bachelor’s degree in Engineering, a related field or equivalent experience
- ASQ certification (CQE, CQA, ISO 13485 lead auditor)
- Direct experience with medical device development that resulted in successful commercialization
- Experience with supporting electro-mechanical devices with sterile disposable and software
- Knowledge of sterilization methods and validations, biocompatibility
- Previous experience in Quality System administration and maintenance in the medical device industry with a focus on compliance functions.
- Hands-on experience in Medical Device product quality assurance and compliance functions
- Thorough knowledge of QSR, ISO 13485 (2003), MDD and MDR requirements applicable to Class II and Class III product environment
- Able to support development of products from initial concept to commercial product
- Attention to detail, good organization skills
- Self directed
- Good communications and interpersonal skills, teamwork, ability to multitask
- Prior supervisory experience