SUMMARY OF FUNCTION:
The Quality Engineer I (QEI) is responsible for quality activities in support of Production and Engineering activities at Medbio. The QEI is responsible for quality management system activities, including maintaining compliance to ISO/FDA requirements. The QEI is an entry level engineer position that requires guidance / mentoring from more senior level engineers or management for many activities and customer interactions.
MAJOR DUTIES AND RESPONSIBILITIES:
- Assist with responsibilities of any other members of the Quality Department as needed.
- Train Medbio personnel on basic quality documents and processes.
- Develop relationships with other departments with the goal of instructing and communicating quality requirements to ensure a high-quality product and compliance to all aspects of the Quality Management System.
- Nonconforming material report (NMR) activities including tracing nonconforming conditions back to their origin, confirming containment activities properly segregated potentially non-conforming material, determining root cause and appropriate corrective action, completing NMR documentation, approving, and escalating to a CAPA when appropriate.
- Develop understanding of customer parts and applications.
- Communicate with customers regarding changes in manufacturing methods (CIMMs).
- Participate in equipment and software validation and mold qualification as needed, including executing requirements.
- Create statistical experiment plans as needed, including Gage R&R, Measurement System Analysis, Process Study, etc.
- Serve as a resource for part measurement issues, including spec interpretation, measurement techniques, vision system programming, etc.
- Coordinate sample submissions (PPAP, approved samples).
- Complete all required documentation, legibly and accurately, on paper and electronically in computer systems using proper grammar.
- Complete documentation (batch record) review related to FDA regulated medical devices and components as outlined in “product release” planning sheets.
- Develop and maintain ISO and FDA compliant quality documents related to products and quality processes, including inspection plans, work instructions, traveler documentation, SOPs, and forms. Assist other departments with their documents.
- Perform and analyze process capability and tolerance interval studies, determining course of action for any outlier, unexpected, or failing results. Write reports and communicate to customer, receiving approval as needed.
- Lead or participate in internal audits and support external audits as requested.
- Participate in supplier audits as requested.
- Maintain a professional relationship with all other employees.
- Learn and follow ISO/cGMP requirements, ensuring that the procedures and systems at Medbio are in compliance, and maintaining a high level of awareness of the requirements among the employees at Medbio.
- Work to achieve Monthly Company goals and metrics.
- Function as a designate for the Quality Manager or other Quality Engineers as requested; typically only if no more senior member of the quality team is available.
- Perform other tasks assigned by the Quality Manager and/or Director of Quality.
- Maintain work habits and safety procedures according to company policy, standard operating procedure, and quality manual.
- Support and adhere to Medbio’s Corporate Mission and Core Values.
- Perform other duties as assigned.
ORGANIZATIONAL RELATIONSHIPS:
The QEI reports to the Quality Manager. Management, Engineers, Team Leaders, and Technical staffing can look to the QEI for clear resolution to specification and/or part-quality issues. The QEI interacts with management, engineers, maintenance, operators, assemblers, suppliers, and customers regarding all aspects of part and process quality.
EXPERIENCE AND/OR EDUCATIONAL REQUIREMENTS:
- Four-year degree (engineering, science, or similar) plus zero to two years of relevant experience or equivalent in years of
experience in Quality related field required
- Certified Quality Auditor, Certified Quality Engineer, or Six Sigma Black Belt Certification a plus
- Preferred experience in a medical device manufacturing environment or similarly regulated environment
- Solid understanding of ISO/cGMP requirements with regard to manufacturing and document control preferred
- Good computer skills (Microsoft Office)
- Advanced math skills
- Moderate blueprint reading skills with understanding of GD&T principles preferred
- Moderate understanding of statistics preferred
- Root cause analysis skills preferred
- Solid written/verbal communication, interpersonal and motivational skills required
- Self-motivation and ability to manage projects with important deadlines required
PHYSICAL REQUIREMENTS:
- Must be able to work a standard 40 hour workweek with occasional overtime including weekends a possibility.
- Sitting and/or standing for extended periods of time as well as some walking within the facility.
- Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet.
- The ability to lift and carry various items up to 20 pounds.
- Pass an audiology screening
Salary range $55k-$65k
