Senior Quality Engineer - Hybrid Role

We are hiring Senior Quality Engineer - Hybrid Role.

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

Client: Major Medical Device Client

Position: Senior Quality Engineer - Hybrid Role

Duration: 12+ months on W2

Location: Mahwah, New Jersey 07430

Pay Rate: $50.00-$55.00/ Hr on W2

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Job Description

Hybrid (Minimum 3 Days On-Site)

Must Haves

Great Problem-Solving and Critical Thinking Skills (4+ years)

• Strong problem-solving and critical thinking abilities.

Ability to Independently Use Engineering Rationale to Make Decisions (4+ years)

• Ability to independently apply engineering rationale and make sound decisions.

Knowledge/Experience with Validation (2+ years)

• Hands-on knowledge and experience with validation activities.

Nice To Haves

• Experience developing or approving SOPs.
• Great communication skills.
• Ability to follow a timeline and track deliverables.
• Self-starter.

Day to Day

• Participate in project team meetings for progress updates.
• Review validation protocols or execution and work with the owner.
• Review SOPs/Procedures and work with the author.
• Approve First Article Inspections.
• Meet with cross-functional teams (Design, Manufacturing Engineering, Project Managers) on deliverable updates and overall project strategy.

Job Description

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

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

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.
• SOP and Risk Management documentation updates and reviews.
• And more.

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

Expected Qualifications:

• Bachelor’s Degree – Biomedical Engineering, Mechanical Engineering, or related field.
• 4+ years of experience in industry required.
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Firm understanding of Medical Device concepts highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concepts highly desirable.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts/theories.
• High level of PC skills.
• Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Be willing 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 who acts with a customer service/stakeholder-focused approach.
• Ability to be the voice of Quality when dealing cross-functionally.
• Excellent English (both oral and written).
• Up to 10% travel may be required.

Regards,

Vishnu Das Natesan

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