Position Title: Quality Engineer/Supervisor

Department: Quality

Location: St. Louis, MO

Reports To: Director of Quality

Classification: Salary - Exempt

Last Updated: July 2022

Position Summary:

This position is responsible for the overall quality of manufactured medical products. In addition, this role leads initiatives for improved quality and cost saving for existing products. This role offers the opportunity to work with customers, sales, manufacturing, purchasing and quality departments.

Essential Job Duties:

• Reviews, maintains, and updates the Quality Assurance Manual and other Quality department procedures.
• Prepares, plans, and leads on behalf of the organization, all external audits both regulatory and customer audits (ISO 13485, FDA, and MDR) related to the products manufactured onsite.
• Leads, plans, and implements corrective actions, internal audits to ensure the highest product quality and continuous improvement.
• Supervises and directs the actions of a Quality Engineering Technician and receiving inspector.
• Works in collaboration with design and manufacturing engineering to implement new products, design changes and to ensure all products and processes meet customer and regulatory specifications.
• Works cross functionally with all departments to ensure that the organization is aligned with the company's quality policies and meets all regulatory and customer requirements.
• Maintains all records regarding quality documentation, calibration, and corrective actions.
• Leads and drives till resolution all customer complaints and corrective actions. Maintains and updates customer complaint documentation.
• Leads team to perform and documentation of FAIs.
• The technical lead on incoming and in process inspection equipment selection and calibration requirements.
• Works with the Director of Quality and Operations to drive total product quality and a spirit of continuous improvement.

Required Education:

• Bachelor's degree or equivalent experience.

Required Experience/Skills:

• Knowledge of Quality Control Systems.
• Experience in high pressure flow control valves a plus.
• Experience with Microsoft Excel, Word, and PowerPoint.
• Knowledge in machining, injection molding, and other manufacturing processes.
• Knowledge in Lean Manufacturing, Design for Manufacturing, ISO Quality Systems and 8D Corrective Actions.
• Strong problem solving and decision-making skills.
• Team player with strategic focus.
• Ability to multi-task several assignments.
• Ability to manage priorities to ensure timely completion of projects.
• Good oral and written communication skills.
• Good organizational abilities, attention to detail.
• Ability to support efforts for continuous improvements in process efficiency and cost reduction.

Desired Experience/Skills:

• Experience in the medical device field or regulatory environment preferred.
• Self-starter, energizing, results-oriented, and able to multi-task.
• Excellent cross-functional teamwork, coordination, and communication skills.
• Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets.
• Results oriented with a high commitment level.

Work Environment:

• Office environment with interaction on manufacturing floor and Engineering Test Lab.

About Control Devices, LLC

Control Devices, LLC ("Control Devices" or "CD") is a leading designer & manufacturer of high-quality flow control valves, condensate removal traps, related components & accessories serving the compressed air, pressure washer, vehicle systems, fire protection, specialty gas, & the industrial, agricultural & food service float valve markets. CD prides itself in the ability to design, innovate & manufacture flow control valves for custom applications & offers a line of standard products that has grown over the years. CD is based in Saint Louis, MO & its products are sold on a global basis to O.E.M.'s, Distributors & End Users.

CD offers competitive compensation, a comprehensive benefits package, paid time-off, steeled-toed shoes reimbursement, casual dress work environment, and a solid 401(k) retirement plan to promote financial security.

Control Devices, LLC provides is an Equal Opportunity Employer. We provide equal employment opportunities to all employees and applicants and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.