Quality Engineer

The Quality Assurance Engineer will utilize analytical techniques and quality methodologies to monitor the performance of products and processes, recommend process improvements and reductions in cost-of-poor-quality (COPQ) and to support the continual improvement efforts.

Responsibilities and Duties

• Designs, implements and evaluates quality assurance processes and sampling techniques, including ownership of our COPQ system determination and documentation of incoming test and inspection plans.
• Ensures compliance to all applicable quality customer-specific systems and requirements.
• Ensures compliance of all quality controlled documentation, document change activities and record retention requirements.
• Assists with providing direction, mentorship, training guidance and day-to-day management of the site quality team.
• Works with all departments to implement process improvements, increase process yields and reduce COPQ.
• Works with Quality Manager/Engineering team to develop a robust Root Cause/Corrective Action program to improve internal and vendor quality performance.
• Team focused with the ability to participate in and lead cross-function teams.
• Participates in proactive team efforts to achieve departmental and company goals.
• Complies with OSHA standards and regulations.
• Performs other duties as assigned.

Knowledge (position requirements at entry):

• Electronic and electromechanical manufacturing processes (PCB, electronic and electromechanical assemblies).
• OSHA standards and regulations.

Skills (position requirements at entry):

• Communication; interpersonal skills as applied to interaction with coworkers, supervisor, the general public, etc. sufficient to exchange or convey information and to receive work direction.
• Interprets customer quality requirements and product drawings, schematics, specifications, etc.
• Strong oral presentation skills.
• Multi-tasking skills.

Minimum Requirements

• Four (4) Year degree from an Accredited Institution.

• 4+ years of direct experience with medical or aerospace quality concepts, FAI, FMEA, metrics and problem solving methodologies, including Supplier Quality, Manufacturing Quality, Auditing, SPC, CAPA processes (internal/vendor/customer), COPQ reduction and program management.

• Demonstrated proficiency in the use of the Microsoft Office suite in the generation of professional documents and reports, and in the use of statistical analysis tools, including DOE and trend analysis.

Preferred Qualifications

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

Safety

• Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources.

Quality Management System (QMS)

• Support and follow all ISO standards. These systems may include, but are not limited to, quality, the environment, health, safety and security.

Supervisory Responsibilities:
N/A

Physical Requirements:

• Be able to perform light physical activity daily.
• Manual dexterity sufficient to reach/handle items, works with the fingers, and perceive attributes of objects and materials.
• Must be able to occasionally lift up to 25 lbs. in an 8 hour shift.
• Must be able to frequently lift 15-50 lbs. in an 8 hour shift.

Software used:

• Microsoft Office suite
• Outlook
• Visio

Working Conditions:

• Requires working indoors in environmentally controlled conditions