Quality Engineer

PRIME ACQUISITIONS LLC•Suwanee, GA

13d•Onsite

About The Position

The Quality Assurance Engineer uses analytical techniques and quality methodologies to monitor product and process performance, recommend process improvements, reduce cost of poor quality (COPQ), and support continual improvement. The role designs and evaluates quality assurance processes and sampling techniques, including ownership of the COPQ system and documentation of incoming test and inspection plans. It ensures compliance with applicable customer-specific quality systems and requirements, controlled documentation, document changes, and record retention requirements. The engineer works across departments to improve processes, increase yields, and reduce COPQ, and collaborates with the Quality Manager and Engineering team on root-cause and corrective-action programs. The position also supports the site quality team through direction, mentorship, training guidance, and day-to-day management. It is a full-time, day-shift role located at Prime Technological Services, LLC in Suwanee, Georgia.

Requirements

Four-year degree from an accredited institution.
At least 4 years of direct experience with medical or aerospace quality concepts, FAI, FMEA, metrics, and problem-solving methodologies.
Experience in Supplier Quality, Manufacturing Quality, auditing, SPC, CAPA processes (internal, vendor, and customer), COPQ reduction, and program management.
Knowledge of electronic and electromechanical manufacturing processes, including PCB and electronic and electromechanical assemblies.
Knowledge of OSHA standards and regulations.
Communication and interpersonal skills sufficient to exchange or convey information and receive work direction.
Ability to interpret customer quality requirements and product drawings, schematics, and specifications.
Strong oral presentation skills and ability to multitask.
Demonstrated proficiency with Microsoft Office for generating professional documents and reports.
Proficiency with statistical analysis tools, including DOE and trend analysis.
Ability to perform light physical activity daily and sufficient manual dexterity to handle items and perceive attributes of objects and materials.
Ability to occasionally lift up to 25 lbs. and frequently lift 15–50 lbs. during an 8-hour shift.

Nice To Haves

Preferred experience with QMS compliance requirements for ISO 9001, AS9100, ISO 13485, or FDA 21-CFR 820 standards.
Lean manufacturing experience is strongly desired.
Experience with Microsoft Outlook and Visio is preferred.

Responsibilities

Design, implement, and evaluate quality assurance processes and sampling techniques.
Own the COPQ system and document incoming test and inspection plans.
Ensure compliance with applicable customer-specific quality systems and requirements.
Ensure compliance with quality-controlled documentation, document change activities, and record-retention requirements.
Assist with direction, mentorship, training guidance, and day-to-day management of the site quality team.
Work with departments to implement process improvements, increase process yields, and reduce COPQ.
Work with the Quality Manager and Engineering team to develop a root-cause and corrective-action program to improve internal and vendor quality performance.
Participate in and lead cross-functional teams.
Participate in team efforts to achieve departmental and company goals.
Comply with OSHA standards and regulations and company safety policies, practices, and procedures.
Report unsafe activities to a supervisor and/or Human Resources.
Support and follow applicable ISO and Quality Management System standards.
Perform other duties as assigned.