Senior Quality Engineer

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

Job summary

Aequor is seeking a seasoned Quality Engineer in Indiana to ensure products meet all quality and regulatory standards. You will evaluate processes, develop QA plans, and lead cross‑functional teams to drive continuous improvement in a medical device environment.

The role requires 5–7 years in quality engineering, a B.S. in engineering with CQE/CRE preferred, and hands-on experience with ISO, QSR, GD&T, and CMMs. Strong collaboration with suppliers and internal departments is essential.

Qualifications

• B.S. in engineering or equivalent with CQE certification preferred.
• 5-7 years of Quality Engineering experience, medical device experience preferred.
• CQE or CRE certification is an asset.

Responsibilities

• Evaluate process methods and equipment to meet performance and quality requirements.
• Establish quality plans for equipment and processes.
• Monitor performance of processes to standards.
• Apply ISO and QSR requirements to processes and suppliers.
• Collaborate with suppliers on new product introductions to ensure quality.
• Assist Manufacturing, Sourcing and Development with regulatory interpretations.
• Develop and maintain department and project budgets.
• Note: duties may vary and are not exhaustive.

Skills

Team collaboration

Quality engineering

Data analysis

GD&T

Regulatory knowledge

Education

B.S. in engineering

CQE certification preferred

Tools

CMMs

Optical comparators

Blueprint reading

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 the company to implement 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 standards.
• Applying ISO and QSR requirements to processes and procedures for internal teams 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.
• 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

• 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 products and a basic understanding of competitive products.

Education

• 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).