Quality Control Coordinator (Biotech)
Job Summary
The Quality Administrator will collaborate closely with suppliers to ensure that products shipped to our customers meet company and client requirements. The position will oversee activities related to product qualification, auditing, product investigations, supplier data analysis, correction and/or implementation of strategic quality systems, packaging, and other operational processes.
Job Responsibilities
- Implement Quality Systems for production and supply base.
- Advise and support customer supplier quality and supplier production personnel on day-to-day quality and production issues.
- Collect and evaluate supplier quality data to identify process improvement opportunities.
- Communicate and instruct suppliers on the use of corrective action processes and quality tools and techniques.
- Collaborate with suppliers directly to create corrective action plans to address process failures.
- Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities.
- Regularly visit suppliers to assist with production and quality issues.
- Perform supplier audits.
- Prepare, update and coordinate PPAP documentation and associated processing.
- Create, issue and complete Supplier Corrective Action Requests.
- Coordinate engineering change requests and deviations between the suppliers and customer quality and engineering teams.
- Establish systems internally and externally to error proof processes, including integrating technology where feasible.
Qualifications
- Experience working in a quality and manufacturing environment.
- Knowledge of stamping and fabrication processes, including tooling and associated quality control methodologies.
- Strong leadership skills and teamwork mentality
- Technical skills include the ability to read and understand engineering blueprints, procedural documents, industry specifications and manuals and apply them to applicable processes and finished goods.
- Strong critical thinking skills, with the ability to teach and coach basic problem-solving techniques and facilitate associated activities.
- Proficient in quality analysis tools and root cause analysis methodologies, including 8D, fishbone diagrams, and 5 Why, PFMEA, SPC, control plans, etc....
- Ability to interface with customers and suppliers, as needed.
· Experience in developing part certification processes (PPAP) and supplier quality measures.
· Strong data analysis and reporting skills.
- Identify, control, and contain nonconforming products.
- Assist suppliers in the development of test methods and inspection plans.
- Travel in and out of town as required.
- Ability to work in fast paced environment on multiple projects.
- Self-motivated with a high level of initiative.
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.
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Travel
Travel required, as needed.
This is a full-time position. Hours of work are Monday through Friday although occasional nights or weekends may be required.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Production
