Quality Engineer - Deland, FL
Reporting to the Quality Manager, the Quality Engineer facilitates the daily activities related to the inspection functions and provides leadership and motivation to achieve the desired level of quality and delivery to internal and external customers. To be successful in this position, it is critical the Quality Engineer has a thorough understanding of the use and application of standards and specifications including ISO 9001, AS9100, Nadcap, ITAR, ISO 13485, ISO 14971, and FDA 21CFR Part 820.
As an integral member of the production floor team, the Quality Engineer will regularly collaborate with Manufacturing, Engineering, customer service, etc., to support customer deliverables and drive continuous improvement.
Essential Duties & Responsibilities:
- Support the Quality team in inspection and quality control procedures with regard to purchased raw material, in-process and finished products to assure that quality control standard is achieved
- Ensure products comply with customer specifications, industry standards, regulatory requirements and Plexus standards. Ensure ABIs comply with specifications and standards.
- Support creation and execution of qualification and validation protocols (Ex: IQ/OQ/PQ) protocols to ensure compliance with Master Validation Plans
- Lead the development of the inspection strategy for incoming/receiving, in-process manufacturing, pre-shipment inspection per information received by participating in NPI meetings
- Serve as the primary customer contact for quality-related issues including specification inquiries
- Assist with response and actions associated with customer quality concerns including complaints, disclosures, and inquiries
- Engage Product/Manufacturing/Process Engineers and other SMEs to address customer quality concerns
- Lead CAPA development in response to customer requests, creation of customer defined quality reports, and provide feedback and documentation to the customer as required
- Support the company’s goal of improving manufacturing quality and efficiency by conducting or assigning inspections, assessing the results and the manufacturing process, and proposing improvements based on the findings
- Balance team workloads, leveraging/flexing to team skills and strengths, effectively managing assignments to ensure deadlines are met
- Lead, motivate and optimize team efficiency and effectiveness
- Ensure all equipment used for product acceptance is calibrated and properly maintained
- Constant communication with General Manager regarding issues and concerns
Required Skills:
- Exceptional organizational skills to establish priorities, and assist in establishing work schedules, allocation of resources, enforcing company policies and procedures, and utilizing resources to provide the greatest efficiencies
- Idea generation with strong analytical, problem solving, critical thinking, and innovation capabilities
- Strong project management and multitasking skills along with the ability to navigate conflicting priorities
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form
- Independent thinker capable of working self-sufficiently as well as within a team
- Ability to communicate (both written and verbal) in a professional and respectful manner always
- Flexible and adaptable to ever-changing priorities and/or processes
- Strong interpersonal skills and ability to work well on cross-functional basis in a positive, collaborative manner
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