| Job Description: |
The QUALITY MANAGER shall be primarily responsible for organizing and executing projects related to new and changed medical device process/products, and shall become the Subject Matter Expert (SME) with regard to Design Control issues.
* The QUALITY MANAGER shall be the Product Design Owner (PDO) and Quality Advocate for all medical device projects.
* He/she will coordinate with Division and Facility team members, including Project Management Office, Regulatory, Marketing, Quality, Technical Operations, and Manufacturing groups to ensure the new/changed products are implemented within the regulatory requirements and approved project parameters.
* He/she will provide guidance to various internal customers for the Design Control and Risk Management process and for the development of product specifications, test methods, risk management, etc.
* He/she will utilize best practices and regulatory expertise for experimental design, fundamentals of statistical process control, sampling rationale, and reliability assurance.
* He/she will lead design control assurance and provide engineering/technical assessments of data that supports the design history files.
* He/she will be responsible for the maintenance of the design history files.
*The QUALITY MANAGER will additionally be responsible for creating and reporting metrics associated with the Design Control and Risk Management processes for presentation in the facility monthly management review.
* He/she will act as the Hayward facility representative for any Corporate/Division initiatives for global implementation and/or harmonization pertaining to Design Control, PDP (Process Development Process), and/or Risk Management processes.
* He/she will also write and execute various local documents and protocols as needed.
* He/she should also have experience developing master quality plans and guides for medical device processes and the associated documentation.
* Requirements 1.
* A Bachelor of Science degree or equivalent experience.
* (Chemical or Mechanical Engineering degree or experience preferred).
*2.
* A minimum of 8 years GMP medical device experience, with at least 2 years as a quality engineering experience perferred.
* 3.
* Minimum 2 years in leadership roles, with multiple direct reports.
* 4.
* Previous responsibility over Design Control and Risk Management issues5.
* ASQ certification or training helpful6.
* Previous experience with project management7.
* Extensive experience with CFR 820 QSRs, current FDA guidance, and ISO 13485 and their practical application.
* 8.
* Extensive and direct experience with PDP, design control, design verification, and design history files.
*9.
* Experience writing and approving Deviations, Exceptions, CAPAs, and/or other Non-conformances.
*10.
* Experience participating in audit situationsPercent Travel Required5%
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