Sr Quality Engineer-Medical/FDA

 

Our client, a leading edge international medical device manufacturer has immediate need for talented Quality Engineer. As an integral member of the Corporate Quality function this position high visibility. Demonstrated successes will afford progression within this growth oriented industry leader. Primary responsibilities will include assessing quality assurance and regulatory programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and guidelines to ensure lasting customer satisfaction. As a key member of the corporate Quality staff this position will have significant travel requirements.

 

The Position:

• Plan, schedule, execute and follow up quality audits of manufacturing sites, suppliers and per regulatory and business priority
• Help develop and maintain corporate policies supporting quality system
• Provide support in the identification, development and delivery of corporate training initiatives
• Assist sites with the development and implementation of quality system remediation activities to achieve compliance standards. In addition, there is the challenge the shall help to identify and communicate “Best Practices” throughout the corporation.
* Assist with site regulatory compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations
• Maintain working knowledge of existing and proposed domestic and international medical device and pharmaceutical industry regulations and guidance documents and their impact on operations.

 The Requirements:

• Degree engineer with 5-10 years experience in a medical devices or an FDA regulated environment.
• Prior experience in auditing is required; hands on experience managing and/or supporting FDA and Notified Body inspection/audits.
• In depth  knowledge of FDA Quality System Regulation, ISO, Medical Device Directive,  and other international requirements.
• Knowledge of all Quality System elements, including complaint handling, CAPA, Design Control, Validation Review and the ability to mentor others in those areas.
• ASQ Certified Quality Auditor and Lead Auditor training are highly desired.

Qualified candidates please be mindful that direct submission to companies subjects you to the massive and turbulence seas of the hiring process—but more importantly precludes you from being represented by an experienced and established search firm –which can greatly enhanced your probably of success!

 

If you have the aforementioned skills and are serious about an exciting and challenging new career opportunity then please forward your resume to Kevin Bock via e-mail to kbock@kbock.net

When you work with Bock & Associates you are working with a search firm that has specialized in this field the last 18 years. Our industry knowledge and Direct Contacts will likely benefit you and your career!

 

 

Kevin Bock

Bock & Associates