Lead Quality Assurance Engineer

2 weeks ago

Covington, United States MILLENNIUMSOFT Full time

Job Title: Lead Quality Assurance Engineer

Location: Covington, GA

Contract Term: 12+ Months

Weekly 40.00 Hours [Mon - Fri]

1st Shift

Overview

We are seeking experienced Quality Assurance Engineers to contribute to a specialized initiative. The primary functions of the Lead Quality Assurance Engineer are outlined below.


Key Responsibilities:


• Support Project Teams or the Quality Department by generating necessary documentation such as RFS, ECR, PQR, etc.


• Develop and evaluate Quality System Documentation.


• Draft and assess Product Documentation.


• Formulate and review Testing Methodologies.


• Create and assess Protocols, Process and Product Validations, and Stability Protocols.


• Provide guidance and direction as needed.


• Prepare and review documents essential for the Design History File.


• Conduct and review Risk Assessments including FMEA, FMECA, or FTA.


• Execute Internal or Supplier Quality System Audits.


• Ensure adherence to Department and Division protocols.


• Engage in professional organizations to communicate contemporary industry standards effectively.


• Collaborate with manufacturing or other Division Facilities.


Summary

This role encompasses various quality engineering functions and related support tasks, fostering knowledge and experience in Quality Assurance, Document Control, and Design Control. Responsibilities include supporting Design Control projects and other duties aligned with the Quality System, Design Control System, Document Control, Manufacturing, and R&D/Product Development departments.


Essential Duties and Responsibilities:

• Represent the Corporation, Division, and Quality Department professionally.

• Act as the Quality Representative on Project Teams, ensuring Design Control principles are applied to Product and Process Changes and New Product Development.

• Provide necessary support for Project Teams or the Quality Department, including documentation generation.

• Develop and evaluate Quality System Documents.

• Draft and assess Product Documents.

• Formulate and review Testing Methodologies.

• Create and review Protocols, Process and Product Validations, and Stability Protocols.

• Provide guidance and direction as necessary.

• Prepare and review documents for the Design History File.

• Conduct and review Risk Assessments such as FMEA, FMECA, or FTA.

• Execute Internal or Supplier Quality System Audits.

• Ensure compliance with Department and Division protocols.

• Participate in professional organizations to communicate industry standards effectively.

• Collaborate with manufacturing or other Division Facilities.

• Travel as required for the above responsibilities.


Qualifications:

To excel in this position, candidates must demonstrate the ability to fulfill each essential duty satisfactorily. The following qualifications are representative of the knowledge, skills, and abilities required:


• Capability to perform detailed engineering tasks under the guidance of a Senior Engineer or Quality Management.

• Understanding of basic applied statistics.

• Knowledge of manufacturing processes.

• Comprehensive understanding of quality systems and their relation to business operations.

• Experience in drafting process, software, and equipment protocols/validations, with a fundamental grasp of validation principles.

• Ability to collaborate effectively within teams and maintain a positive work environment.

• Strong communication skills (verbal, written, and presentation).

• Understanding of Basic Engineering Principles.

• Effective time management skills.

• Ability to manage multiple tasks simultaneously.

• Proficiency in translating quality requirements into product specifications.

• Ability to interpret Regulations, Corporate, Division, and Department Procedures.


Education and Experience:

• A minimum of a B.S. in Engineering, Engineering Technology, or Science.

• Preferred certifications from the American Society of Quality (ASQ) such as CQE, CQA, CQM, etc.

• At least 3 years of experience in an FDA-regulated industry, ideally in product development programs.

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