Position Summary

We are seeking a highly motivated and detail-oriented Quality System Engineer to join our dynamic Quality team. In this role, you will be responsible for developing, implementing, maintaining, and continuously improving our Quality Management System (QMS). You will be the technical expert on quality standards and regulations, ensuring our processes are robust, compliant, and effective. The ideal candidate is a proactive problem-solver with a strong foundation in quality principles and a passion for driving systemic improvements.

Key Responsibilities

1. Quality Management System (QMS) Maintenance & Improvement:

Administer and maintain the QMS in compliance with relevant standards (e.g., ISO 9001, AS9100, IATF 16949, ISO 13485).
Manage the document control process, including the creation, revision, approval, and obsolescence of quality system documents (procedures, work instructions, forms).
Plan, schedule, and support internal and external audits. Lead audit teams and manage the audit finding closure process.
Host and support audits by regulatory bodies and customers (e.g., FDA, FAA, NB).

2. Non-Conformance & Corrective Action (CAPA):

Lead and facilitate the investigation of non-conformances, customer complaints, and other quality issues to determine root causes.
Manage the Corrective and Preventive Action (CAPA) system, ensuring timely and effective implementation of solutions.
Utilize root cause analysis tools (e.g., 5 Whys, Fishbone Diagram, Pareto Analysis) to drive to fundamental causes.
Verify the effectiveness of implemented corrective actions.

3. Process Improvement & Data Analysis:

Analyze quality data (e.g., scrap, rework, audit findings, customer returns) to identify trends and opportunities for improvement.
Utilize statistical analysis and Quality Engineering tools (e.g., SPC, FMEA, MSA, Control Plans) to monitor process performance and capability.
Lead or participate in cross-functional process improvement projects using methodologies like Lean Six Sigma.

4. Risk Management:

Support the development and maintenance of the organization's Risk Management framework.
Facilitate Failure Mode and Effects Analysis (FMEA) activities for products and processes.
Ensure risks are identified, assessed, and mitigated effectively throughout the product lifecycle.

5. Training & Culture:

Develop and deliver training on QMS processes, quality standards, and best practices to employees across the organization.
Promote a culture of quality and continuous improvement throughout the company.

Qualifications & Experience

Required:

Bachelor's degree in engineering (Mechanical, Industrial, Electrical, or related field) or a scientific discipline.
5+ years of experience in a Quality System, Quality Engineering, or similar role within a regulated manufacturing environment.
Demonstrated, hands-on experience with ISO 9001 or other industry-specific quality standards (e.g., AS9100, IATF 16949, ISO 13485).
Strong experience with root cause analysis and the CAPA process.
Proven experience conducting internal audits.
Proficiency in reading and interpreting technical drawings, GD&T, and specifications.
Strong analytical and problem-solving skills, with proficiency in Microsoft Office Suite (especially Excel).

Preferred:

Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certification (ASQ or equivalent).
Lean Six Sigma Green Belt or Black Belt certification.
Hands-on experience with Statistical Process Control (SPC), Measurement System Analysis (MSA), and Design of Experiments (DOE).
Experience with Quality Management Software (e.g., EtQ, MasterControl, SAP-QM).
Experience in the [Your Specific Industry, e.g., Medical Device, Aerospace] industry.

Skills & Competencies

Meticulous Attention to Detail: Ability to spot inconsistencies and inaccuracies in documentation and processes.
Excellent Communication Skills: Capable of effectively communicating complex quality issues and requirements to both technical and non-technical audiences, both in writing and verbally.
Strong Interpersonal Skills: Ability to work collaboratively in a cross-functional team environment and influence others without direct authority.
Proactive & Self-Motivated: Takes initiative to identify and address quality issues before they escalate.
Organized & Methodical: Excellent project management and organizational skills to handle multiple tasks and priorities.

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