SUMMARY

Under minimal supervision from the Quality Manager, the Senior Quality Engineer will support Engineering and Quality Assurance activities and assist Quality Control and Regulatory as part of a comprehensive Quality Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Read and conform to all company policies and procedures.

• Interact and communicate with internal departments, including Purchasing, Shipping / Receiving, Engineering, Customer Service, and Sales/Marketing.

• Authority to place product on hold.

• Involved with new product development (NPD) process and the support of existing and previously commercialized products.

• Review and approve engineering drawings and assist in determining Critical-To-Quality Dimensions.

• Create, Review, and Approve Inspection Plans and Inspection tools as required.

• Create and Support validations for new and existing products and processes, including packaging and sterilization.

• Create and Support IQ, OQ, and PQ activities for equipment and additive implants.

• Perform and support Gage Repeatability and Reproducibility (Gage R & R) studies.

• Perform and support First Article Inspection / Inspections on Prototypes.

• Perform Statistical rationales as required.

• Support supplier quality management activities, including qualification, evaluation, and investigations.

• Support Post Market Surveillance activities.

• Support Complaint/NC/CAPA teams through the identification and development of corrective action plans, verification, and closure.

• Perform and support Design and Process FMEA activities.

• Collect, analyze, and summarize data and make recommendations as required.

• Support and prepare for site-level internal, external, supplier, and customer audits.

• Provide quality support to identify and resolve quality issues to ensure safe and effective medical devices.

• Interact and coordinate activities with other departments, support, and customers.

• Identify and implement opportunities for continuous improvement.

• Create and update Quality System Procedures and Instructions when applicable.

• Supports Quality, Engineering, and Regulatory to meet company and department objectives.

• Other duties as assigned by management

SUPERVISORY RESPONSIBILITIES

Not Applicable

QUALIFICATIONS

• Excellent communication skills and the ability to work with people at all levels.
• Ability to work independently and in a team environment.
• Strong organizational skills, attention to detail, self-motivator, ability to multi-task and meet timelines.
• A working knowledge of desktop computer office software and e-mail is required.
• Understand calibration fundamentals.
• Experience using inspection equipment such as calipers, micrometers, height gauges, plug and ring thread gauges, and pin gauges. Optical comparator and Vision system experience preferred.
• Understanding of SOLIDWORKS or 3D modeling is preferred.
• Knowledge and understanding of Medical Device Regulations / Certifications such as 21CFR820 & ISO13485:2016.
• Medical Device experience is preferred.

EDUCATION and/or EXPERIENCE

Engineering degree or equivalent and at least 8 years’ experience with mechanical inspection of precision machined products, medical device industry experience preferred

CERTIFICATES, LICENSES, REGISTRATIONS

Not Applicable

EXEMPTION

Exempt

PHYSICAL DEMANDS 

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. In addition, the employee should be able to stand, walk, use hands to finger, handle, or feel and reach with hands and arms. In addition, the employee must occasionally lift and move up to 25 pounds.

WORK ENVIRONMENT 

The work environment characteristics described here represent those an employee encounter while performing this job’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The working environment is typical of an office environment. The noise level in the work environment is usually moderate.

SUMMARY

Supports Quality Inspection Department by completing visual and functional inspections of Medical Devices. Under minimal supervision prints labels using ERP System. Packages and labels medical devices and complete documents per Quality Management Systems requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Print labels using ERP System.
• Package and label medical devices.
• Read, understand, and interpret engineering (blueprints) drawings is a plus but not required.
• Conduct visual and functional inspection of finished product for accuracy and adherence to specifications.
• Perform transactions in ERP system, as necessary.
• Identify nonconforming product and report to the Quality team.
• Maintains the Work In Progress inventory location by restocking and retrieving requested products.
• Perform Work In Progress inventory audits as required.
• Read and conform to all company policies and procedures.
• Interact and communicate with internal departments.
• Other duties as assigned by management.
• Conduct in-coming visual inspection of finished product /certificates of conformance / material certification / document review for accuracy and adherence to specifications as required.
• Transfer of physical product to stockroom.
• Upload product records into the digital repository.

SUPERVISORY RESPONSIBILITIES

Not Applicable

QUALIFICATIONS

• Good communication skills, both verbal and written.
• Ability to work independently and in a team environment.
• Strong organization skills, attention to detail, self-motivator, ability to multi-task and meet timelines.
• Basic math and problem-solving skills.
• Working knowledge of desktop computer office software and e-mail is required.
• Experience using inspection equipment such as calipers, micrometers, height gauges, plug and ring thread gauges and pin gauges is a plus but not required.
• Familiar with 21 CFR (Code of Federal Regulation), Part 820 and ISO 13485:2016 is plus but not required.

EDUCATION and/or EXPERIENCE

Minimum High school diploma or equivalent. Medical device industry experience preferred but not required.

CERTIFICATES, LICENSES, REGISTRATIONS

Not Applicable

EXEMPTION

Non-Exempt

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand, walk, use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Working environment is typical of an office environment. The noise level in the work environment is usually moderate.