Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 10-15+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
QC Supervisor – direct hire / full time
Quality Operations Manager
QA / RA / Document Control
Allen, TX 75002
Supervises and coordinates the activities of Quality Control Technicians at Incoming QC, In-Process QC, and Finals QC to ensure adherence to established quality standards. Provides Leadership and support to Quality Control Technicians while ensuring internal/external customer demands are being met. Facilitates prioritization as related to ensuring the support of schedule attainment. Establishes inspection procedures, defines sampling plans based on risk assessments, and qualifies test methods and inspection equipment. Recommends changes in specifications of materials, parts, products, and processes based on inspection data. Provides the necessary training to ensure employee competency. Leads cross-functional team meetings for process improvements, audits, CAPA and project work. Performs root cause investigations for internal non-conformances and support activities around those investigations.
- Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience.
- A minimum of 3 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical.
- Experience using measurement equipment such as calipers, micrometers, vision systems, height gages, tensile and compression test equipment, gage pins, etc.
- Ability to work well on a team and has a cooperative attitude.
- Knowledge in MDSAP, FDA Quality System Regulation, MDD, and/or ISO 13485.
- Organization skills must be at a high level in order to ensure all personnel are achieving goals and tasks
- Must possess technical writing, project management and fundamental problem-solving skills.
- Previous experience performing laboratory and/or mechanical testing required.
- Computer literate at intermediate level in MS Office Suite. Familiarity with Minitab statistical software preferred.
- Excellent writing and communication skills. The individual should be detail oriented and have good deductive and problem-solving skills.
- Supervisory experience desired.
- Self-motivated employee that requires little direct supervision.
- Ability to travel up to 10% of the time.
- Supervise QA Technicians, ensuring that the required inspections are being performed per company policies and procedures.
- Ensure that each QA Technician is prioritizing the proper inspection work in alignment with production/customer order needs throughout the company.
- Oversee inventory levels in, both, all M-locations and Q-locations in the ERP system.
- Administrate the Environmental Monitoring Program, including the performing of any tests and submitting necessary test samples to laboratory to ensure compliance to internal procedures.
- Provide inputs into and execute outputs from Material Review Board activity and Non-Conforming Material Reports (NCMR) on a timely basis, including re-inspection and QC disposition activities.
- Provide/coordinate training for new QC Technician personnel to perform component/product inspections, as well as subsidize the overall inspection effort when necessary. Maintain the employee competency matrix to monitor training progress and cross-training needs.
- Analyze data using valid statistical techniques. Writing conclusions or recommendations based on data analysis.
- Work to improve all aspects of quality control inspections. This includes equipment to perform inspections, methodologies of inspections, and streamlining the inspection process.
- Audit each inspection area in a regular basis to ensure compliance to all company policies and procedures.
- Use project management tools to calculate estimated time for performing a series of tests within the normal inspection process. Make recommendations about procedures for optimizing the testing process.
- Write performance reviews for each QC Technician/QC Lead and participate in the execution of those reviews with each applicable employee.
- Act as the direct QC contact for all manufacturing processes throughout the company, including ad hoc discussions on product prioritization, performance feedback and special requests.
- Review departmental performance data to ensure the appropriate prioritization is being employed and to identify opportunities for improvement.
- Make necessary updates to controlled documentation in order to facilitate continuous improvement in all aspects of the Quality Control process.
- Write technical reports associated with qualifications, quality improvements and CAPA projects.
Notables / Benefits:
- Mid-size company with great company culture that is well diverse
- Have a voice in the company
- Average tenure for employee population is 10-15+ years
- 401k with employee matching available
- Paid vacation and other excellent benefits
An Equal Opportunity Employer
Job Type: Full-time
- measuring equipment: 3 years (Required)
- Quality: 3 years (Required)
- lab or mechanical testing: 3 years (Required)
- supervisory: 2 years (Preferred)
- regulated industry: 2 years (Preferred)
- Minitab: 2 years (Preferred)
- Paid time off
- Health insurance
- Dental insurance
- Healthcare spending or reimbursement accounts such as HSAs or FSAs
- Other types of insurance
- Retirement benefits or accounts
- Gym memberships or discounts