Quality Engineer/Supervisor

Position Title: Quality Engineer/Supervisor

Department: Quality

Location: 1450 Carr Lane Ct St Louis Mo 63102

Reports To: Director of Quality

Classification: Salary - Exempt

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 QMS) 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 Quality Inspectors and Quality Engineers. Coaches, counsel and disciplines employees when necessary.
• Trains employees in the company established work procedures and processes.
• 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.
• Works with suppliers to drive corrective actions to maintain a high level of quality. Leads team to manage FAIRs and documentation.
• Leads and drives till resolution all customer complaints and corrective actions. Maintains and updates customer complaint documentation.
• 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 along with 2 - 5 years of successful supervisory and quality experience in a manufacturing environment.

Required Experience/Skills:

• Experience in the medical device field or regulatory environment preferred, EU MDR, FDA GMP & MDSAP
• Experience in high pressure flow control valves a plus.
• Experience with Microsoft Excel, Word, and PowerPoint.
• Knowledge in machining and other manufacturing processes.
• Knowledge in Lean Manufacturing, Design for Manufacturing, ISO Quality Systems and 8D Corrective Actions and the PPAP process
• 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:

• 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 (or "CDI"), an HBM Holdings company headquartered in Greater St. Louis, is a leading designer and manufacturer of engineered flow control solutions in the compressed gas, compressed air, oil & gas, and liquid controls markets. The company offers custom valves and flow control solutions for companies who place a premium on quality. Control Devices leverages operational excellence and flow control expertise to deliver trustworthy flow control products and innovative solutions that protect life and our planet.

CDI offers competitive compensation, a comprehensive benefits package, paid time-off, personal protective equipment reimbursement for safety shoes and prescription safety glasses, casual dress work environment, and a solid 401(k) retirement plan to promote financial security.

Control Devices, LLC 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.