QA ENGINEER

ESSENTIAL JOB FUNCTION :

The QA Engineer is responsible for facilitating process and software validation activities to assure products and processes are in compliance with standards. The QA Engineer is responsible for continuously improving processes and obtaining optimum product quality by using CAPA methodologies. The QA Engineer will work independently to determine appropriate actions to fulfill management objectives, and is responsible for supporting the investigation of non-conformances by developing CAPA and using quality tools such as root cause analysis, statistical sampling, capability studies, problem solving, or any other statistical method.

Job Functions include but are not limited to:

• Perform process validation and capability.
• Perform software validation and ensure QMS compliance .
• Drive quality/manufacturing projects initiatives utilizing DMAIC and/or Lean methodologies, APQP, and/or SPC to achieve and sustain improvements.
• Perform MSAs
• Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
• Champion activities including: containment, root cause analysis, corrective actions, and follow-up/verifications concerning customer complaints, closing complaints inside the target time frame.
• Risk analysis - Lead/facilitate or participate on a team using FMEA, Fault Tree or other suitable methods for existing and/or future processes and products
• Lead/facilitate or participate on a team focusing on root cause analysis for internal and external nonconformities using 5-why's, fishbone or suitable methods, and challenge corrective actions through verification of effectiveness.
• Lead/facilitate or participate on continuous improvement projects using Lean, DMAIC, Kaizen methodologies.
• Physically walk processes, with/without team, gain consensus for key areas for improvement.
• Develop and administer training to personnel on the quality function, quality methodologies, and quality issues as required.
• Create documentation, reports, presentations, and records consistent with internal and external requirements, complying to ISO, safety, environmental and/or regulatory agencies.
• Provide professional verbal and written communication to external and internal parties, complying to company policies.
• Champion any projects/task/duty as defined by the Quality Head with metrics that track achievable goals.

[Apply now at ; JOB REQUIREMENTS: Job Requirements: Education: Bachelor's degree in Industrial Engineering, Chemistry, or Material Science. Additional certifications in ASQ, SPC, Lean, or Six Sigma are a plus. Experience: 1-2 years in a Quality Assurance role. Experience with ISO 9001:2015, GMP, and automotive/medical products is a plus. Skills:

• Ability to work in team concept.
• Ability to resolve conflicts professionally.
• Provide/maintain “can-do” attitude with emphasis on customer service.
• Software proficiencies: intermediate user level: Minitab, MS Office, e-mail; basic user level: instrumentation programming.