Quality Manager

Aequor; Warsaw (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

Zimmer is seeking a Quality Engineer to ensure medical device quality from design through production. You will apply ISO/QSR standards, lead quality improvement projects, and collaborate with cross-functional teams to resolve issues and implement robust processes.

Ideal candidates hold a BS in engineering with a CQE/CRE, 5–7 years in quality engineering, and proven ability to drive deadlines and budgets while maintaining strong supplier relations.

Qualifications

• BS in engineering or equivalent with CQE/CRE preferred.
• 5–7 years in a Quality Engineering role, medical device exp preferred.
• Ability to communicate clearly with multiple departments and suppliers.

Responsibilities

• Evaluate processes and equipment to meet quality requirements.
• Develop quality plans for equipment and processes.
• Monitor process performance to standards and apply ISO/QSR rules.
• Collaborate with manufacturing, sourcing, and development teams.
• Develop and maintain department and project budgets.

Skills

Team collaboration

Quality engineering

Communication

Statistical analysis

Blueprint reading

GD&T / CMMs

Education

B.S. in Engineering

CQE or CRE certification

Tools

Microsoft Office

Optical comparators

CMMs

Job description

Responsible for gathering relevant, factual information and data in order 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 Zimmer to implement Zimmer 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 Zimmer 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

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 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 existing Zimmer products and a basic understanding of competitive products

Education:

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 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)