Quality Assurance Engineer {Mahwah, NJ}

Matlen Silver; Mahwah (NJ); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

401(k) plan (employee contributions)

Job summary

Matlen Silver is seeking a Quality Assurance Engineer in Mahwah, NJ for a 12‑month contract. You will provide quality engineering support across QA, QC and preventative activities in operations and related functions.

You will develop methods for process control, testing and inspection to ensure products meet design specs. Expect involvement in FAI, PPAP, change control, validations and risk management.

Qualifications

• Bachelor's degree in a technical field and 2+ years of industry experience.
• Experience with quality systems and processes in medical device or similar industry.
• Strong communication and analytical skills; able to document and present results clearly.

Responsibilities

• Develop and implement quality methods for process control, testing and inspection.
• Lead First Article Inspection (FAI) and PPAP activities; support change control assessments.
• Validate equipment and processes; update SOPs and risk documentation as needed.
• Collaborate across sites to improve quality performance and regulatory compliance.

Skills

Communication skills

Attention to detail

Problem solving

Team player

English proficiency

Education

Bachelor's Degree - Biomedical Engineering, Mechanical Engineering or related field

Tools

MS Word

MS Excel

PowerPoint

Job description

Job Title: Quality Assurance Engineer

Duration: 12 months

Location: Mahwah, NJ

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 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).

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.
• Good understanding of engineering and quality concepts / theories.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.
• Have knowledge of Risk Based and statistical concepts is desirable.

About Matlen Silver

Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.

Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: [e-mail] // 908-393-8600

Benefits

• Health, vision, and dental insurance (single and family coverage)
• 401(k) plan (employee contributions only)