Quality Engineer

PEKO Precision Products Inc•Rochester, NY

26d•$60,000 - $89,000

About The Position

PEKO Precision Products: We Make Products That Matter PEKO is a full-service, debt-free, privately-owned contract manufacturer with over 50 years embedded in the Rochester, NY community. In collaboration with our valued business partners, we deliver new product development (NPI) strategies for product commercialization and provide solutions in the medical, industrial, defense, and renewable energy industries. Enriching life is a crucial component of what we do daily. The Opportunity: Quality Engineer Your Role: Under the direction of the Quality Director, you will assist in elevating and systematizing engineering and manufacturing processes. Daily activities will require you to proactively identify potential issues to mitigate risk, improve product quality, manage industry and regulatory compliance and assist in delivering corporate strategic initiatives.

Requirements

Associate degree in Engineering or equivalent.
2+ years of quality control experience in a manufacturing environment
4+ years of experience utilization of 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.

Nice To Haves

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).

Responsibilities

Analyzes quality performance data and metrics to identify and drive improvement opportunities.
Actively promote and participate in a cross-functional teamwork environment.
Facilitate and promote the use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action for customer complaints and internal nonconformances.
Understand and promote overall compliance with AS9100/ISO9001 and 13485 specifications as they relate to product conformance and contractual requirements.
Understanding of inspection methodologies used to determine compliance for machined and assembled products.
Manage, conduct, and support internal and external audits, publishing findings and recommendations.
Lead in the implementation of assurances, 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.
Demonstrate a productive work ethic and commitment to quality that sets the standard for PEKO Standards.
Assist with other duties as assigned by the Manager.