Description
Job Overview:Provide quality engineering support to Manufacturing Operations by resolving quality related issues, improving product quality, investigating customer complaints and reducing costs. Utilize the Company's Correction and Preventive Action system to pursue continuous improvement of the Company's Quality System and products. Assist with supplier support and play an active role in cost reduction projects that support Lean initiatives. Actively participate on Research and Development project teams, complete validations, and conduct validations as it relates to quality of products.
Main Responsibilities:
- Investigate/analyze customer complaints to monitor customer complaint trends and maintain compliance to Company's complaint system.
- Investigate/analyze in-house and field failures (returns) and monitor quality trends. Propose and implement possible solutions/improvements utilizing the Company's Corrective and Preventive Action (CAPA) system.
- Initiate supplier corrective actions and assist Purchasing to continuously improve supplier quality and enhance supplier relationships.
- Initiate, review, and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
- Design and/or specify inspection and testing procedures/systems to ensure Company's products conform to specifications and quality standards.
- Initiate, review, and approve disposition for Nonconforming Product.
- Participate on product development teams, including developing Quality Plans and Risk Management Plans.
- Interface with personnel from all areas of the company to foster improved quality, reduced cost, and process improvement.
Qualifications:
- Bachelor Degree in Engineering Discipline
- At least 4-5 years Engineering experience in FDA-regulated industry
- Performance of root cause investigation (use of investigation tools (fishbone, 8D) a plus)
- Excellent organization skills
- Excellent attention to detail
- Above average written communication skills
- Ability to work well independently and as part of a team
- Ability to analyze information from regulations, SPC charts, data tables, diagrams, and blueprints
- Ability to prioritize workload, multitask, and meet deadlines