Engineer, Quality Assurance - Onsite

Ledgent Technology; Mahwah (NJ); Sur place; USD 52 000 - 59 000; Plein temps

Résumé du poste

Ledgent Technology in Mahwah, NJ is seeking a Quality Assurance Engineer onsite to support quality engineering activities across operations and related functions. You will develop and implement methods for process control, testing and inspection to ensure products meet design and regulatory standards.

This role requires a bachelor's in biomedical or mechanical engineering and at least two years of experience, with knowledge of QMS, change control, PPAP, FAI, and ISO 13485.

Qualifications

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering or related field.
• 2+ years of industry experience.
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• ISO 13485 and EU Regulations, GDP, GMP knowledge desirable.
• Excellent communication and attention to detail.
• Proficient with MS Word, MS Excel and PowerPoint.
• Strong cross-functional collaboration and problem solving.

Responsabilités

• Develop and implement methods and procedures for process control, testing and inspection.
• Support First Article Inspection (FAI) strategy development, execution and approvals.
• Support PPAP and change control processes and change impact assessments.
• Validate equipment and processes; update SOPs and risk management documentation.
• Collaborate with multi-site teams and stakeholders to drive quality improvements.

Connaissances

Attention to detail

Communication skills

Problem solving

Team player

Multitasking

English proficiency

Formation

Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related field

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Engineer, Quality Assurance - Onsite (JN -102026-433961) Mahwah, New Jersey

Salary: USD38 - USD43 per hour

Engineer, Quality Assurance - Onsite

Location: Mahwah, NJ

Pay Rate:

$38.00 - $43.00/hr.

Job Description:

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 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

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience.

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
• 2 + years of experience in industry required
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept 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.
• Have knowledge of Risk Based and statistical concepts is desirable.
• Problem solving and analytical skills.
• Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and 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).