Quality Software Validation Manager

Job Title: Quality Software Validation Manager
Location: Warsaw, IN 46580
Contract: 12 Months Contract

Job Summary:
Responsible for gathering relevant, factual information and data to solve quality-related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time-dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside the Company to implement the Company's quality goals.

Principal Duties and Responsibilities:

• Evaluating process methods and equipment to meet performance and quality requirements.
• Establishing quality plans for equipment and processes for general and specific product performance needs
• Monitoring performance of processes to a standards
• Applying ISO and QSR requirements to processes and procedures for Company's and outside suppliers; Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled
• Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations
• Developing and maintaining department and project budgets
• Total percent (not to exceed 100%)
• *Individual percentages should be greater than or equal to 5%.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions " for purposes of the ADA.

Skills:

• Expected Areas of Competence (i.e. KSAs)
• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Facilitates team efforts on quality engineering projects.
• Ability to deliver, meet deadlines and have a results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
• Knowledge of statistics, process control, and process capability
• Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
• Thorough knowledge base of the existing company's products and a basic understanding of competitive products

Education/ Experience Requirements:

• B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE).
• Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
• 5-7 years of experience in a Quality Engineering role; Medical device strongly preferred, or an equivalent combination of education and experience.
• Combination of education and experience may be considered (in evaluating experience relative to requirements)