Gig Harbor Categories:
Director / Sr. Director Quality Systems Generic Medical Devices
THIS JOB HAS EXPIRED
General Description:The Director / Sr. Director, Quality Systems is responsible for implementing and maintaining a regulatory program that ensures compliance with the appropriate regulatory statutes in a cost effective structure that support the companys business objective. This position will also be responsible for the analysis and timely reporting of compliance status of the Quality System and will assist in the development and implementation of effective quality system improvement activities and will monitor the implementation of actions taken as a result of audit activities and provide management oversight and report on the progress of those actions.
Key Duties And Responsibilites:
- Develops, improves and maintains the companys quality system for complaint handling, CAPA, process deviation, document control and internal audit processes to support regulatory compliance in a cost effective structure
- Develops and/or implements quality assurance and quality control policies and procedures for class II implantable medical devices
- A strong change agent that drives a continuous improvement culture that builds quality in, identifies and mitigates risk, focusing on preventive action
- Determines product disposition for all materials, packaging, components, WIP and finished goods in a sub-contract manufacturing environment
- Manages and oversees all non-conformances and company (including sub-contract manufacturing) related CAPAs ensuring root cause analysis, corrective and preventive actions and final dispositions are performed in a timely and compliant manner
- Plan and direct performance of staff: Motivate employees, assist in goal setting, provide development opportunities and performance feedback, address complaints and resolve issues
- Applies Clinical knowledge to timely and thorough complaint documentation
- Proactively identifies areas for process improvements and partners with management to develop effective solutions that promote the companys business objectives
- Performs analytical, statistical and trending analyses on complaint data to support timely management review and proactive response or corrective action
- Reviews/writes product investigations reports and provides analyses, trending data, including initiating formal investigations and/or corrective action requests resulting from product complaints
- Prepares well-written Med-Watch forms for FDA reporting within prescribed timelines
- Provides support on field corrective actions and recalls including investigation, corrective action planning and effectiveness checks
- Coordinates, plans, and executes Quality System and Regulatory compliance internal audits at Generic Medical Devices, Inc. to assess and maintain compliance with all applicable FDA and international regulatory requirements, including ISO 13485
- Reports results of audits and the resulting corrective actions to management in a defined format including the categorizing of the level of Regulatory Compliance Risk. Provide compliance assessment of audit findings and prepare appropriate reports to auditees and management, and then formulate and implement proactive regulatory compliance strategies and controls
- Evaluates corrective action plans, evaluate, and provide consultative support to auditees relative to the implementation of regulations and their implementation
- Recognizes and alerts management to risk, legal, labeling or other product issues
- Participates in development and implementation of QSR and MDD-ISO training programs
- Provides support to development teams by participating in project reviews and auditing for compliance. Secondary responsibilities include review of design changes to ensure changes to approved products are properly reviewed and approved
- Member of Supplier Evaluation Review Board
- Performs other duties and special projects as required
Supervisory Responsibilites:
- Supervises complaint handling staff, Manager Quality Systems and Document Control Personnel
- Provides strategic direction and oversight for quality processes, systems and controls
Travel Requirements:
Up to 15 travel required
Minimum Requirements And Qualifications:
The requirements listed below are representative of the knowledge, skill, and or ability required for this position.
- Bachelors degree in life science discipline or Biomedical Engineering or experience equivalency. Masters Degree a plus
- 10years experience in medical device quality functions
- 5 years in a supervisory role (at a manager level a plus)
- 3 years of relevant clinical experience a plus
- Experience in a leadership role in a start-up or early stage medical device company
- Experience establishing and growing a quality system including design controls, complaint handling, CAPA, internal audit, supplier qualification, etc;
- Experience working with contract manufacturers a plus
- Demonstrated ability to stay abreast of changes in Quality Standards, Regulations, Quality Metrics, audit techniques and TQM practices
- Proven experience establishing and maintaining a complaint handling department
- Extensive knowledge of the following regulations: US FDA 21 CFR Part 820, 803, 806, Medical Device Directive, Medical Device Directive for Vigilance Reporting, and Canadian requirements for Vigilance Reporting
- Medical device experience supporting complaint handling and/or MDR reporting required. Must understand the medical conditions and procedures associated with device complaints and product technologies
- Must have excellent written and oral communications skills
| Location: | 2201 34th Avenue NW Gig Harbor, WA 98335 United States |
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THIS JOB HAS EXPIRED
Generic Medical Devices
Investors: Kaiser Permanente Ventures, Latterell Venture Partners, The Grosvenor FundsAll Jobs: at Generic Medical Devices
| Web Site: | www.genericmedicaldevices.com |
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| Headquarters: | 2201 34th Avenue NW Gig Harbor, WA 98335 United States |
| Industry: | Medical Devices and Equipment |
