Working under the direction of the Quality Assurance Supervisor, provide support to establish and maintain the Quality Management System for a medical device manufacturer. Performs internal auditing and follows up on CAPA activity. Supports quality assurance training and development of quality system documentation and records maintenance. Administers the Change Control system and monitors production processes for process control and analysis to identify nonconformities and persistent quality issues.
Initiates, cooperates or participates fully as appropriate in using the team approach in solving problems and suggesting improvements that enables Whip Mix to live up to its mission and values.
Job Functions and Responsibilities
| Quality System Documentation - Helps in the development and updating of quality system documentation and records. Supports records and document control, and production and process control. Aids the Quality Supervisor in the transition to new standards as they develop. (Essential) - 20% |
| Change Management - Administrates the change management system. Ensures validation of changes and associated risk analysis are completed and documented. (Essential) - 20% |
| Quality System Auditing - Leads scheduled risk based internal audits. Updates the Audit Log, documents findings and works with departments to provide effective corrective action. Participates in external audits. (Essential) - 20% |
| Corrective and Preventive Action (CAPA) - Takes an active role in facilitating the Corrective Action process. Takes initiative in problem-solving for continuous quality improvement relative to raw materials, product testing and product performance. Communicates continuous improvement suggestions to management regarding quality issues and concerns of customers. Submits quarterly CAPS report to management. (Essential) - 20% |
| Technical Writing - Helps develop technical documentation quality procedures, work instructions, calibration procedures, quality plans and quality related forms. (Essential) - 10% |
| Process Control – Plans, conducts and oversees test and inspection of materials and products (ex Sampling) to ensure quality is maintained. (Essential) - 10% |
| Performs other functions or duties as assigned. (Supplemental) |
Knowledge, Skills, Abilities, & Worker Characteristics
5 years of experience in Quality Assurance with an ISO 13485/FDA cGMP manufacturing company
Degree in a technical or engineering field
ASQ Certification and ISO auditor Certification
- Demonstrated knowledge of ISO 13485 and FDA cGMP.
- Excellent technical writing skills and attention to detail.
- Communication skills necessary to interact successfully within a team framework.
- Good computer skills and basic typing and word processing skills.
- Able to read and understand manufacturing orders and complex work instructions, and material handling documents.
- Sufficient math knowledge to develop a statistically valid protocol to validate product design and process capability.
- Must be an organized self-starter with very strong decision making ability. Able to prioritize work and meet deadlines.
Summary Education & Experience Required
- A degree in a technical or engineering field is desired, or 5 years of equivalent experience in Quality Assurance with an ISO 13485/FDA cGMP manufacturing company.
- ASQ Certified and Certified ISO auditor preferred.
- CAPA experience.
- Advanced skills in Excel and MS Word desired developing and updating documents.
- Must possess a thorough knowledge of service processes (Operations, Maintenance, Customer Responsiveness, and Engineering) and quality assurance principles
