Senior Quality Engineer Product Development

Our client focuses its business on the manufacture of innovative medical devices in key surgical specialty areas.  We are pleased to be able to present this exciting opportunity for a talented individual to play a lead role as a Senior Quality Engineer in lovely Arizona


Senior Quality Engineer - Product Development


RESPONSIBILITIES
• Develop physical and functional test methods to ensure specifications
• Write, review and approve design verification and validation protocols and reports
• Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
• Conduct and /or coordinate testing outlined in protocols and test methods.
• Perform process improvement, control and monitoring on manufacturing processes.
• Provide technical direction during design transfer activities.
• Conduct complaint investigations.
• Participate in project planning, budgeting, scheduling and tracking. Coordinate and lead internal and supplier audits.
• Develop and implement procedures to comply with corporate, industry and regulatory standards. Understand and follow company procedures on regulatory requirements.
• Provide support to the regulatory department in writing technical submissions. Provide positive example and actively promotes compliance to all standards.
• Maintain a professional working relationship with internal and external customer and support staff.


KNOWLEDGE AND SKILLS
• Strong interpersonal, communication and Project Management skills including ability to lead cross functional teams and training.
• Advanced statistics, application of DOE.
• Ability to develop and control a budget and engineering cost analysis
• Ability to analyze and optimize manufacturing and quality systems.
• Advanced product, design, prototyping skills and review functions.
• Software application skills.
• Ability to generate engineering proposals.
• Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.


EXPERIENCE/EDUCATION:
Bachelors degree in a technical field plus
Seven years experience in the medical field or closely related industry
 Or
Masters Degree plus three years
Quality Engineering Certification (ASQ) or equivalent.


Excellent Salary and Benefits!


Shore Consultants is the fastest growing most comprehensive Pharmaceutical /Medical Device Recruiting Firm within the MRI Network. Why?  We deliver over and over and over; one quality placement at a time. MRI is the largest search and recruitment organization in the world today. Come and see the ultimate standard in client and candidate satisfaction. Visit