JOB TITLE: Quality Engineer
LOCATION: Fond du Lac, Wisconsin
GF Health Products, Inc. (“GF”) is a nationally known manufacturer and distributor of medical devices and related products in the medical/surgical, homecare, long term care, and consumer markets. GF’s steel fabrication facility located in Fond du Lac, Wisconsin is responsible for the manufacture of our Basic American Medical Products® line of beds for long term care facilities, our Lumex® line of beds for our homecare business unit and our Hausted® line of ambulatory chairs and stretchers for acute care facilities.
With the growth of our business and introduction of new products, GF is currently seeking an experienced, self-motivated, Quality Engineer with experience in a regulated environment such as ISO 9000, TS-16949, 21 CFR 820 /ISO 13485. This position is located in our Fond du Lac Wisconsin manufacturing facility.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Participate in New Product Development Risk Analysis activities during project launch including FMEA and PFMEA.
Assist the quality and materials management teams in the supplier qualification process and develop receiving inspection and Ship to Stock (SOS) program.
Work interdepartmentally to develop and review processes to ensure quality for new and existing products, including, but not limited to the following: various inspection techniques and procedures to ensure product integrity to design specifications (ex: set gauge parameters), incoming inspection of raw materials, in process inspection of manufactured component parts, and final inspection.
Reduce all processes to a written document to be followed by effected personnel. Train personnel on the processes to be used. Develop training logs to demonstrate operator training. Audit training and training logs to ensure compliance.
On an ongoing basis, monitor the process validations in order to implement capability studies.
Communicate with management as to major obstacles/issues involving the launch of a new product.
Obtain and maintain documentation involved in the launch of the new product. Educate others within the organization as to the requirements and the time involved to meet these requirements.
Monitor and document follow up on product evaluations for completion and effectiveness.
Investigate customer concerns and perform evaluations, prepare reports defining the extent of the issue.
Assume lead role in investigating potential manufacturing/process issues with a goal of identifying potential root cause and assessing potential finished device impact.
Work with suppliers, management, engineers and manufacturing associates in the resolution of quality problems. Keep all parties apprised of status.
Communicate with Quality department as to the status of returned product analysis (DC evaluations) and the need for additional information appropriate to report.
Prepare any necessary documentation relative to a product complaint together with other members of the Quality department.
Prepare needed documentation for New Product Development teams..
Participate as a trainer in Quality Control and Manufacturing employee training programs.
Participate in internal audits conducted by internal employees and regulatory agencies.
Work with the Quality Audit group to assess current procedures/work instructions related to the operations of the company and address deviations/findings.
Travel to company, supplier and customer locations as may be required from time to time (5%).
Other projects and daily activities as may be assigned from time to time.
Bachelor’s degree (continuing education and relevant work experience may be considered)
A minimum of 1 year work experience in the quality field, including audit experience.
Excellent interpersonal/communication/problem solving skills (both verbal and written).
Attention to detail and good analytical skills.
Good organizational skills and accurate prioritization abilities.
Strong independent work ethic and ability to manage multiple tasks, individually and as part of a team.
Ability to lift and move from 10 to 50 pounds.
ASQ CQE is a plus
Proficient in all MS Office software
All qualified applicants will receive consideration for employment without regard to race, color, gender identity or expression, age, religion, intellectual disability, mental disability, physical disability, including but not limited to blindness, unless it is shown that such disability prevents performance of the work involved, medical condition, handicap, national origin, ancestry, sexual orientation, marital status, domestic partnership status, parental status, military status, veteran or military discharge status, source of income or housing status or any other status protected by applicable law.
GF Health Products, Inc. is a drug free workplace