Job Summary:

The primary function of the Quality Engineer is to drive preventative quality measures that support the needs of our medical device customers. This position is expected to assist in other quality assurance functions, such as addressing customer quality complaints, ensuring compliance with certifications, and facilitating the competition of internal quality defects, helping to move the plant towards a total quality manufacturing facility. This position will work closely with our customers, as well as all levels of the company.

Job Description:

• Design inspection and testing mechanisms to conduct quality assurance tests and perform statistical analysis to assess the cost of and determine the responsibility for product or materials that do not meet required standards and specifications.
• Drive preventative quality measures that support the needs of medical device customers.
• Assist in other quality assurance functions, such as addressing customer quality complaints, ensuring compliance with certifications, and facilitating the completion of internal quality defects, helping to move the plant towards a total quality manufacturing facility.
• Work closely with customers, as well as all levels of the company.
• Work directly with medical device customers to lead the timely completion of supplier corrective action requests (SCARs), corrective and preventive actions (CAPAs).
• Collaborate with internal functions on corrective actions that include training, process improvements, Standard Operating Procedures (SOP) updates, quality audits, and validation efforts.
• Prepare and present reports and compliance documentation to medical customers.
• Maintain and review documentation for regulatory submissions and inspections related to product quality; read customers’ specs, artworks, and drawings.
• Ensure products meet all regulatory requirements, including FDA, ISO, and other relevant quality standards.
• Assist in maintaining and developing Quality Management System (QMS) to requirements of ISO 9001:2015, Quality Manual, and current company objectives.
• Provide guidance and training on medical quality standards and best practices to internal teams.
• Perform root cause analysis events and ensure the completion of action items, which include training, CAPA activities, quality audits, validation efforts, and standard work revisions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Participate in companywide continuous improvement projects.
• Facilitate customer quality visits and support audits.
• Develop and deliver training programs to build skills and reinforce quality standards.
• Perform dimensional and functional inspections and tests on equipment including calipers, pin gauges, and pressure gauges.

Supervisory Responsibilities:

• None

Minimum Qualifications of Position:

• The position requires a Master’s degree or foreign equivalent degree in Engineering, Chemistry, or closely related field.
• The qualified candidate must have at least 6 months of experience in a quality assurance specialist/inspector position, or closely related occupation.
• The qualified candidate must also have at least 6 months of experience with all of the following: (a) resolving supplier complaints, such as supplier corrective action requests (SCARs), corrective and preventive actions (CAPAs), and root cause analysis; (b) performing quality assurance and validation tasks, such as gathering and interpreting complex data; (c) drafting documentation, records, and reports ensuring compliance with business procedures and quality system regulations and ISO standards; (d) maintaining and developing quality management systems (QMS); (e) assessing products and materials during and after manufacturing to ensure they meet required quality standards; and (f) performing dimensional and functional inspections and tests on equipment including calipers, pin gauges, and pressure gauges.
• All experience may be gained concurrently.

Working Conditions and Physical Requirements:

• Infrequent reaching, bending, and stooping.
• Ability to lift up to 50 pounds.
• Frequent standing, walking, and sitting.

EEO Statement:

The Imagine Group provides equal employment opportunities to all employees and applicants for employment and prohibits 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.