home >> medical / pharmaceutical >> job board >> post

Posted by: CHRIS INGALLS <cingalls@natleng.com> on August 03, 2009 at 21:00:22. Click here to reply to this post via Email.

Contract / Temp to Perm / Permanent: Permanent
City: BOSTON, MA & PITTSBURGH, PA
Country: United States

Two (2) positions :(1) Braintree, MA (1) Leetsdale PA
Salary to mid $60k with 5% bonus.
Previous medical device experience & auditing suppliers
Six sigma desirable
Company representative, very professional, strong communicator with solid writing skills,
a technical and analytical thinker, energetic and enjoys change
reports to newly hired Global Supplier Mgmt Manager

Supplier Quality Systems Engineer

Responsible to ensure that products manufactured will conform to corporate and applicable regulatory requirements (MDD 93/42/EEC, ISO13485, 21CFR 820, CMDR and applicable local regulations).

• Works closely with cross-functional teams across departments including senior management levels to ensure we are doing business with high-quality suppliers and providing appropriate feedback to our suppliers.
• Develops / provides significant supplier input for new products, in collaboration with manufacturing, R&D & Marketing
• Active participant in regard to suppliers for Design Control and improvement projects to ensure compliance to product specifications, customer requirements and quality systems requirements by the FDA and other regulatory authorities.
• Recommends and evaluates new suppliers to grow the business and improve operational efficiency and quality levels.
• In conjunction with corporate Quality System, reviews customer complaints to determine corrective action in regard to suppliers.
• Participates in risk management activities to identify, design and process risks and ensure mitigation in compliance with corporate procedures in regard to supplier activities.
• Leads teams/projects related to supplier complaint investigation, CAPA, cost reduction and quality system excellence. Deploys TQM tools including six sigma
• Conducts external supplier audits as assigned to ensure QMS compliance

Specific educational and skill requirements:

• Bachelors Degree required.
• 2+ years quality assurance / supplier quality engineering experience.
• Proficient computer knowledge and experience with Microsoft Office
• Excellent oral and written skills
• Detail oriented and strong ability to multi-task
• Black Belt six sigma desirable