Duties and Responsibilities:

• Responsible for participation in implementing new production lines.
• Responsible for collaborating with Quality and Operations to develop and implement controls to improve our product output and improve quality control.
• Responsible for validation of new and current processes and equipment.
• Responsible for corrective and preventive actions.
• Responsible for hands-on process improvement activities.
• Responsible for leading small teams to enhance product quality and production capabilities.
• Responsible for investigating and troubleshooting production issues.
• Responsible for ensuring that workflows, processes, and products comply with regulations.
• Responsible for label design in line with relevant standards.
• Responsible for validation and maintenance of cleaning and passivation systems for medical devices
• Responsible for analyzing packaging and sterilization configurations to optimize cost
• Involved in clean room expansion and optimizing workflow
• Monitoring and analyzing quality performance.
• Review and approve quality document changes.

· Leading and implementing Lean initiatives that include designing and implementing continuous improvements, developing best practices, measuring process improvements, and establishing visual management and ensure implementation of best practices for production.

• Write and execute test protocols.
• Analyze process data to reduce material scrap and to optimize processes.
• Document all manufacturing processes in accordance with our ISO standards.
• Interface with outside vendors for manufacturing, measurement, and test equipment selection.

Qualifications:

• Requires a Bachelor's degree in Engineering or a combination of college coursework and experience
• At least five years’ work experience in a regulated industry (medical device preferred)
• Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations 21 CFR Part 820, ISO 13485:2016, EU MDR, ISO 14971:2019 and ISO 10993
• Demonstrated knowledge and understanding of UDI, ISO 15233-1:2016 and ISO 28219:2017 Labeling Requirements
• Experience working with production lines in a hands-on nature
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
• Excellent computer proficiency (MS Office – Word, Excel and Outlook)
• Strong analytical skills with the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.)
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
• Experience leading and conducting audits
• Certified Quality Engineer preferred

Work Environment While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals and other materials. The noise level in the work environment and facility grounds can be loud.

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling and climbing all day. The employee must frequently lift or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Requires travel between buildings as well as to and from retail/wholesale suppliers. May require travel to remote locations.

Pay: $120,000.00 - $139,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan
• Vision insurance

Work Location: In person