Quality Engineer

Department: Quality

Reports To: Quality Manager

Work Schedule: 7:30 4:30 or 8:00 to 5:00

Travel Required: 0 to 25%

POSITION SUMMARY

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.

ESSENTIAL FUNCTIONS

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

POSITION QUALIFICATIONS

Competency Statement(s)

  • 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

PPAP’s

Preferred

  • 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

Application

Employment Desired

Can you work any shift?

Can you work overtime including weekends?

Are you able to perform the essential functions of the job for which you are applying for with or without reasonable accomodation?

Referral Source

Have you ever worked for our company before?

Do you know anyone who works for our company currently?

Please read carefully before signing. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for Aved Electronics, LLC to hire me. If I am hired, I understand that either Aved Electronics, LLC or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of Aved Electronics, LLC has the authority to make any assurance to the contrary. As a condition of employment, all Employment Offers are contingent upon successful completion of a background check conducted by a third-party provider for Aved Electronics, LLC. I attest with my signature below that I have given to Aved Electronics, LLC true and complete information on this application. No requested information has been concealed. I authorize Aved Electronics, LLC to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.