Senior Engineer, Quality Assurance Engineering - Onsite

Ledgent Technology; Mahwah (NJ); On-site; USD 50,000 - 83,000; Full time

Job summary

Ledgent Technology is seeking a Senior Engineer, Quality Assurance Engineering for an onsite role in Mahwah, NJ. You will provide quality engineering support across QA, control and preventative activities within operations and other business functions.

You will develop methods for process control, testing and inspection to ensure products are free of flaws and function as designed, while leading FAI/PPAP and change-control initiatives.

Qualifications

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering or related field.
• Experience supporting EU-MDR programs.
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• 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. Proficient with Word, Excel and PowerPoint.
• Willingness to travel up to 10%.

Responsibilities

• Support First Article Inspection (FAI) strategy development, execution and approvals.
• Contribute to PPAP and change control processes and impact assessments.
• Assist with equipment and process validations and risk management documentation.
• Maintain SOPs and QA documentation updates and reviews.
• Advise on quality improvements and regulatory compliance across sites.

Skills

Excellent communication

Attention to detail

Problem solving

Analytical skills

Self-starter

Education

Bachelor's Degree in Biomedical Engineering

Bachelor's Degree in Mechanical Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Senior Engineer, Quality Assurance Engineering - Onsite

Pay Rate: $50.00 - 60.00/hr.

Location: Mahwah, NJ

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

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
• Experience supporting EU-MDR programs
• 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).
• Up to 10% travel may be required
• Bachelor's Degree in Engineering field REQUIRED
• Great problem solving and critical thinking skills (4+)
• Able to independently use engineering rationale make decisions (4+)
• Knowledge/Experience with Validation (2+)

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.