QUALITY ENGINEER - INNOVATE MEDICAL, LLC
Required Education, Training, and Experience
- Bachelor’s Degree in Engineering or Science related field
- Minimum five (5) years of experience in engineering / quality within a regulated manufacturing setting
- Working knowledge of the ISO 13485 or ISO 9001 standard
- Proficient in Microsoft Office software (Word, Excel, Outlook, Projects, Teams, etc.)
- Demonstrated project management skills
Preferred Experience and Training
- Experience in medical packaging and sterilization
- Experience leading engineering and validation projects
- ASQ Certification (CQE, CQA, CQM, Six Sigma Green or Black Belt)
- Working knowledge of FDA 21CFR Part 11, 801, and 820 regulations
- Knowledge of employee and plant safety requirements
- Experience in writing and implementing quality system procedures
- Statistical analysis training
- Proficient in performing risk analysis
- Proficient in using engineering tools such as FMEA
- Experience using root cause analysis tools
- Mid-tier business/industrial management experience
- Leadership / Management / Supervisory skills
- Strong written and verbal communication skills
- Strong organizational skills
- Collaboration skills
- Analytical and research skills
- Critical problem-solving skills
- Adaptation skills
- Decision making skills
- Coaching skills
Reports to: CEO
Position Type/Expected Hours of Work:
This is a full-time, salaried position, exempt from overtime pay. Normal work hours are Monday through Friday, 8:30-5pm; 40 hours per week.
The Quality Engineer has responsibility for working in collaboration with the Quality Manager to ensure the company’s compliance with our quality management system. An essential function of the Quality Engineer is to maintain a strong presence on the production and warehouse floor to engage and lead staff in quality related activities. The Quality Engineer will lead the company in all projects involved in product manufacturing, packaging, sterilization, and distribution per required standards and regulations, and will provide a statistical and risk-based engineering approach to development of specifications, project plans, quality improvement projects, and control plans. The Quality Engineer is supported by QC staff.
Essential Duties and Responsibilities
- Responsible for adhering to company policies, procedures, work instructions, and all regulatory agency requirements (FDA, OSHA, and EEOC)
- Responsible for adhering to Innovate Medical Employee Handbook
- Responsible for company compliance to the Innovate Medical Quality Management System per the company Quality Manual, ISO 13485, and FDA CFR Parts 11, 801, and 820.
- Responsible to complete orientation, training modules, competency assessments, annual cGMP training, and continued education in engineering / quality.
- Responsible for development and execution of engineering and validation protocols, such as equipment qualification and packaging validation activities.
- Responsible for leading employees in all steps of projects for validation of packaging equipment and processes, and improvement projects.
- Responsible for quality improvement projects involving in-process packaging activities.
- Responsible for oversight of all QC Inspection, Testing, and Calibration Activities.
- Responsible for good documentation practices for all engineering and quality related records.
- Responsible for creation or revision of company procedures to assure compliance to standards and regulations.
- Assists in resolution of customer complaints, changes, deviations, investigations, and audits.
- Responsible for qualifying suppliers and purchased materials.
- Responsible for training QC staff on inspection methods and techniques.
- Assists in general supervision of QC staff.
- Responsible to follow all written procedures.
- Ensure clean and safe work environment.
- Adequate hearing and communication abilities
- Exposure to moderate noise
- Frequent standing and walking
- Reaching with hands and arms
- Lifting and moving up to 50 pounds
- Adequate close, distance, peripheral, and color vision abilities