Manufacturing Quality Assurance Engineer

We are hiring Manufacturing Quality Assurance Engineer.

Please let me know if you are interested or anyone who might be interested.

Client: Major Medical Device Client

Position: Manufacturing Quality Assurance Engineer

Duration: 12+ months on W2

Location: Mahwah, New Jersey 07430

Pay Rate: $35.00-$43.00/ Hr on W2

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Job Description

Job Summary

As a Quality Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities within operations and other business functions.

You will be responsible for developing and implementing methods and procedures for process control, process improvement, testing, and inspection to ensure that products are free of flaws and function as designed.

Key Responsibilities

You will be expected to support:

• First Article Inspection (FAI) strategy development, execution, and approvals.
• Production Part Approval Process (PPAP).
• Change control processes and change impact assessments.
• Equipment and process validations.
• Standard Operating Procedure (SOP) and Risk Management documentation updates and reviews.
• Other quality engineering activities as required.

You will advocate for and lead the execution of initiatives and projects to enhance quality performance within the business and ensure compliance with applicable regulations and standards.

Required Qualifications and Skills

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• 2+ years of industry experience required.
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• A firm understanding of medical device concepts is highly desirable.
• Familiarity with ISO 13485, EU regulations, GDP, and GMP concepts is highly desirable.
• Excellent communication skills and strong attention to detail.
• Good understanding of engineering and quality concepts and theories.
• High level of computer proficiency.
• Proficiency in Microsoft Word, Microsoft Excel, and Microsoft PowerPoint.
• Self-starter with an efficient work style and the ability to handle multiple tasks in a fast-paced environment.
• Willingness to work as part of a multi-site team.
• Knowledge of risk-based and statistical concepts is desirable.
• Strong problem-solving and analytical skills.
• Ability to build strong relationships by fostering open communication, respect, and trust.
• Strong team player with a customer service- and stakeholder-focused approach.
• Ability to represent and advocate for Quality when working cross-functionally.
• Excellent English communication skills, both written and verbal.

Regards

Vishnu Das Natesan