Position Specific Requirements:
Direct the Quality Engineering department in its role supporting product development, manufacturing, quality control, and insuring continued compliance to internal and external quality and regulatory requirements.
- Provide complete, accurate quality plans for each assigned project. This includes planning for new product development, design and process changes, and additions to existing product lines. Maintain quality plans at all stages throughout product life.
- Plan and implement validation activities using sound statistical principles and fully document them in compliance with the Quality Management System and applicable standards.
- Work with suppliers and contract agencies to provide documentation demonstrating that products and services meet the requirements of the Quality Management System and applicable standards.
- Identify and review changes in regulatory requirements that affect the quality system. Create and maintain Standard Operating Procedures relating to quality engineering functions, such as risk management, validation, and design control, based on these changes.
- Manage the validation system.
- Participate in cross functional design and development teams.
- Mentor quality engineers and others on statistical techniques, validation, and external standards.
- Authors and reviews documentation related to and provides direction, oversight, and training for engineering staff to: Evaluate protocols and reports to ensure compliance to external standards and internal standards and procedures. Provide expertise in risk management and analysis techniques when facilitating completion of process FMEAs within a cross functional team. Evaluate risk during review of NCRs. Participate in Process Validation and Design Transfer activities. Participate in the development and implementation of Production Master Control Plans (PMCP). Ensure the use of statistically valid sampling techniques. Author the Quality, Risk and Usability sections of Production Control Quality Plans (PCQP) Responsible for working with Operations to ensure compliance, cleanliness, and safety on the floor. Develop, install and provide support for maintenance of control charts on the floor. Remediate legacy products and documentation as required.
- Contributes to the team effort by accomplishing related tasks as necessary.
Bachelor’s or Master’s Degree in Engineering or Sciences. MBA and ASQ certification desireable.
Minimum of five years’ experience in Quality Engineering in the medical device industry.
Minimum of one yearexperience in leading engineers required.
Experience in related engineering areas; Production or Non Conformances is beneficial.
Strong computer skills, including Minitab statistical software and MS Office applications including Microsoft Project.