Reports To: Quality Manager
Work Schedule: 7:30 4:30 or 8:00 to 5:00
Travel Required: 0 to 25%
Aved Electronics is looking for a Quality Specialist/Quality Engineer to develop, manage maintain and improve processes & databases for product compliance requirements on sourced components/products, meeting customer specifications, compliant to regulatory directives and quality standards. Process will support the planning, coordination, and execution of assigned deliverables.
Focuses on environmental sustainability shall comply to directives such as, but not limited to, RoHS, REACH, Conflict Minerals, CA Prop65, etc. Key individual will support a fast-paced environment, dealing with complex regulatory systems and QMS, to provide structure and guidance to team members.
Reasonable Accommodations Statement To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform essential functions
Essential Functions Statement(s)
- Work with supply management team to prepare, review, and submit various regulatory documents to external parties
- Maintain a deep understanding of new and existing regulations that may impact the organization's products and processes
- Provide administrative support on compliance matters
- Organize and assist in meetings supporting product compliance activities and projects
- Maintain agendas and minutes for QMS processes; communicate requirements, where applicable
- Participate in contract management meetings and regulatory projects to develop databases and processes
- Communicate to suppliers on changes or when new requests are received from customers
- Support Change Control processes by reviewing, and approving changes to Production and QMS.
- Submit and address requirements in supplier or customer portals
- Collect, analyze, and report information from various sources such as Quality & Operations to monitor performance, identify weaknesses/opportunities, recommend improvements for manufacturing processes
- Data entry and follow-up for NCRs, Deviations, RMAs and MRBs. Investigate CARs initiated by QM for process completion.
- Generate/Review SOPs and Work Instructions for modification and clarity
- Data collection for pre & post manufacturing processes
- Support internal audit & validation processes
- Work with other departments to establish and maintain productive cross functional relationships
- Able to initiate and drive change through team collaboration
- Able to work independently or as directed in a fast-paced environment
- Clerical entry & scanning; Support quality functions as/where directed by QM
- Attention to Detail
- Accountability-Ability to accept responsibility and account for his/her actions.
- Accuracy-Ability to perform work accurately and thoroughly.
- Relationship Building -Ability to effectively build relationships with customers and co-workers.
- Reliability -The trait of being dependable and trustworthy.
- Analytical Skills-Ability to use thinking and reasoning to solve a problem; Able to read and interpret drawing (GD& T)
- Excellent written and verbal communication skills
- Works well under pressure and meets tight deadlines
- Fantastic organizational and time management skills
- Strong decision-making and problem-solving skills
- Meticulous attention to detail
- Must comply with state regulations and guidelines
- Manufacturing Knowledge preferred: PCB, Electronic Devices, Electro-mechanical assembly
SKILLS & ABILITIES:
Education: BS/AS in engineering or technical discipline with 2+ years in Quality manufacturing (Contract or OEM) to ISO 13485 standards
Experience: At least 2 years of product compliance for manufacturing components or devices
Computer & Communication Skills: Tech savvy, and highly computer literate with capability in email, MS Office and related business and communication tools.
Knowledge and use of MiniTab.
Gage R & R
- Validation Knowledge for let OQ and PQ complying to ISO 13485 and CFR 820 per FDA
- Knowledge of FMEA1 PPAP1 SPC, APQP and MSA
- Analytical & Statistical creation and Reporting
- Auditing experience or certification to ISO 9001, AS9100 and ISO13485
- Skill solving approach with considerations to cause and effects to other departments through problem identification and strategic thinking
- Manufacturing Knowledge for Battery assemblies
- Knowledgeable in IPC J-Std-001, IPC-A600, IPC-610, IPC/WHMA-A-620 Workmanship Standards
- Create presentations for communication