Quality Engineer

About the role

The Quality Engineer plays a pivotal role in elevating and systematizing engineering and manufacturing processes. They are responsible for identifying potential issues to mitigate risk, improving product quality, managing compliance, and supporting corporate strategic initiatives.

Responsibilities

• Analyzes quality performance data and metrics to identify and drive improvement opportunities.
• Actively promotes and participates in a cross-functional teamwork environment.
• Facilitates and promotes the use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action for customer complaints and internal nonconformances.
• Understands and promotes overall compliance with AS9100/ISO9001 and 13485 specifications as they relate to product conformance and contractual requirements.
• Understands inspection methodologies used to determine compliance for machined and assembled products.
• Manages, conducts, and supports internal and external audits, publishing findings and recommendations.
• Leads in the implementation of assurance, process controls, and corrective and preventative actions (CAPA) related systems designed to meet or exceed internal and external requirements.
• Drives continuous improvement and prevention of future failures by helping facilitate the implementation of corrective action.
• May be accountable for projects/programs and developing methods and parameters, project methodology, and/or project proposals.
• Demonstrates a productive work ethic and commitment to quality that sets the standard for PEKO standards.
• Assists with other duties as assigned by the Manager.

Requirements

• Associate degree in Engineering or equivalent.
• 2+ years of quality control experience in a manufacturing environment.
• 4+ years of experience utilizing Quality Management Systems (QMS).
• 4+ years of creating and/or managing Design History Files (DHF) and Device Master Records (DMR).
• Knowledge of ISO 13485 and AS9100; ability to establish quality protocols and procedures that align with requirements.

Preferred Qualifications

• Bachelor’s degree in engineering or equivalent.
• Strong communication, negotiation, team moderation skills, and ability to manage time and workload constraints.
• Good understanding of QA methodologies, tools, and processes.
• Knowledge in the application of quality methods and problem-solving tools (TQM, Six Sigma, 8D, 5-Why, Lean Manufacturing, or other continuous improvement methodologies).

Qualifications

• Basic Qualifications:
• Associate degree in Engineering or equivalent.
• 2+ years of quality control experience in a manufacturing environment.
• 4+ years of experience utilizing Quality Management Systems (QMS).
• 4+ years of creating and/or managing Design History Files (DHF) and Device Master Records (DMR).
• Knowledge of ISO 13485 and AS9100; ability to establish quality protocols and procedures that align with requirements.

Skills

• Knowledge of inspection methodologies used to determine compliance for machined and assembled products.
• Understanding of AS9100/ISO9001 and 13485 specifications.
• Experience in leading internal and external audits.
• Ability to implement assurance, process controls, and corrective and preventative actions (CAPA).
• Strong problem-solving and continuous improvement skills.

Benefits

• Competitive Compensation
• Tuition Reimbursement (IRS Allowable pre-tax Max)
• 401K, Medical, Dental, Vision
• Flexible Spending & Health Savings Accounts
• Life, Short and Long-Term Disability
• Recognition Awards & Discretionary Benefits

Pay

A reasonable estimate of the compensation range for this position is $60,000 - $89,000 per year. The wage range for this role considers a wide range of factors when making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational requirements.

Schedule

N/A