Site Quality Leader

For more than 80 years, our client’s engineers and product specialists have partnered with customers to produce highly engineered connectivity and sensing solutions that make a connected world possible. Their focus on reliability, durability, and sustainability exemplifies their commitment to progress. The unmatched range of their product portfolio enables companies, large and small, to turn ideas into technology that can transform how the world works and lives tomorrow.

Role Description:

• The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions. 
• This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls. 
• The Site Quality Leader will report to the Global Head of Quality Operations.

Responsibilities:

• Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.

Develop and implement systems to assure that development as well as production teams receive support in the following areas:

• Quality planning, including inspection techniques and sampling methods
• Statistical Analysis
• Application of required regulatory standards

Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum:

• Delivery of raw materials and components
• Manufactured devices and equipment
• Documentation associated with these functions
• Develop, track, and report on the following administrative systems:
• Department metrics
• Department objectives
• Personnel development and training
• Support regulatory agency and customer quality audits.
• Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.
• Responsible for assisting and training associates in concepts of probability and statistics.
• Responsible for failure appraisal and analysis (internal and external).
• Authority to place products or processes on hold.
• Design and develop forms and instructions for recording, evaluating, and reporting quality data.
• Corrective and Preventive Action program
• Based on operational/quality requirements, assist in test equipment selection and validation.
• Utilize formal problem solving techniques to resolve product and/or process related issues.
• As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.
• Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
• Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..

Requirements:

• Bachelor's Degree with a scientific or engineering emphasis.
• ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.
• 7-10 years experience in a related regulatory environment.
• Experience should include positions at senior levels within the medical device organizations.