Site Quality Leader

WhiteCrow Research; Wilsonville (OR); On-site; USD 90,000 - 120,000; Full time

Job summary

WhiteCrow Research is seeking a Site Quality Leader in Wilsonville, Oregon, responsible for overseeing Quality Assurance and Engineering functions. You will ensure compliance with regulatory requirements such as 21 CFR 820 and ISO13485 while supporting production and development teams.

The ideal candidate has a Bachelor's degree with a scientific or engineering emphasis and 7-10 years of experience in the medical device industry. ASQ Certification and Six Sigma credentials are recommended.

Qualifications

• 7-10 years experience in a related regulatory environment.
• Experience at senior levels within medical device organizations.

Responsibilities

• Supervise and develop Quality Assurance and Quality Engineering functions.
• Ensure compliance with regulatory requirements of 21 CFR 820, ISO13485, and MDR.
• Develop and implement systems for quality planning and statistical analysis.
• Lead administrative systems for department metrics and objectives.
• Support regulatory audits and ensure product conformity.

Skills

Quality planning

Statistical Analysis

Regulatory compliance

Problem-solving techniques

Cross-functional team leadership

Education

Bachelor's Degree with a scientific or engineering emphasis

ASQ Certified Quality Engineer recommended

Six Sigma Green/Black belt recommended

Job description

We are global talent research, insight, and sourcing specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house talent acquisition teams.

About our client

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.

About the role

• 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.

As a Site Quality Leader, you will be responsible for...

• Ensuring 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.
• Developing and implementing 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
• Developing and implementing 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.
• Assisting and training associates in concepts of probability and statistics.
• Failure appraisal and analysis (internal and external).
• Having authority to place products or processes on hold.
• Designing and developing forms and instructions for recording, evaluating, and reporting quality data.
• Corrective and Preventive Action program
• Based on operational/quality requirements, assisting in test equipment selection and validation.
• Utilizing formal problem solving techniques to resolve product and/or process related issues.
• As required, leading cross-functional teams to support resolution of product and/or process related issues or objectives.
• Working with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
• Being innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..

What you already have...

• 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.