This position is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry.  The incumbent will cross-functionally support all quality activities and enforce regulatory requirements in support of new product development activities.

The position requires a self-motivated, self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills.  The incumbent will be knowledgeable with all aspects of large capital/new product development projects and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities.  Additionally, as new products are developed, the incumbent will also be required to develop quality strategies that are applicable for the new product.

The Staff Quality Engineer II reports to the Associate Director, Quality Management.

Primary Responsibilities:

• Serve as a multi-functional team member, establishing quality requirements and providing guidance for sustaining and n product development projects.
• Review process development/validation protocols for effectiveness and compliance to Corporate Guidelines.
• Assess risk commensurate to product design requirements and regulatory compliance within sales regions as new products are developed.
• Assist in developing methods to measure, validate and assure quality standards are achieved for applicable product lines.
• Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
• Establish/maintain documentation for compliance and effectiveness.
• Develop monitoring systems and action plans designed to maintain stability of the manufacturing process and to correct adverse situations.
• Maintain knowledge of current technological advancements and industry standards for regulatory and compliance where deemed necessary and appropriate.
• Use disciplined problem-solving processes and skills to diagnose and prevent/solve product design and manufacturing process issues.
• Develop quality strategies to improve product quality as well as provide for more efficient processing of materials/products.

Qualifications:

The successful candidate must have the following:

• Bachelors Degree in Science, Engineering or a related technical field
• A minimum of 8 years relevant experience with a combination of equivalent education
• Requires experience in Design Control applications as it applies to New Product Development within the medical device industry
• Medical device experience in a high volume manufacturing environment 
• Quality engineering skills in technical tools
• Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements (FDA, ISO)

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