Senior Quality Engineer Job Snapshot Location:

Mahwah, NJ | Hybrid (minimum 3 days onsite)

Pay:

$52

•$60/hour

Shift/Schedule:

1st Shift, Monday

•Friday, 8:00 AM

•5:00

PM Employment Type:

Contract Work Type:

Full-time Experience Level:

Mid Level Duration:

Through December 2027 Opportunity Summary Join a global medical device manufacturer whose products are used by healthcare providers and patients every day. In this role, you'll be a key contributor on a high-priority EU regulatory compliance project, making sure a portfolio of products meets the standards required to stay on the market. You'll work with a collaborative team of 8 engineers, partner closely with design, manufacturing, and project management, and act as the voice of Quality across the project. Occasional travel (up to 10%) may be required. Responsibilities Lead First Article Inspection (FAI) strategy, execution, and approvals for a portfolio of medical device products. Plan, execute, and approve Production Part Approval Process (PPAP) deliverables with manufacturing engineering and suppliers. Drive change control activities and change impact assessments to keep products compliant with EU-MDR requirements. Review and update SOPs, procedures, and risk documentation in partnership with document authors. Support equipment and process validations and report project progress to cross-functional teams. Qualifications Required Bachelor's degree in Engineering (Biomedical, Mechanical, or related field) 4+ years of industry experience, including 2+ years supporting EU-MDR programs or initiatives Knowledge of Change Management and Quality Management Systems (QMS) principles, the ability to make independent decisions using engineering rationale, and proficiency in Microsoft Word, Excel, and PowerPoint Preferred Medical device industry experience Familiarity with

ISO 13485, EU

regulations, GDP, and GMP Knowledge of risk-based and statistical concepts Experience tracking deliverables on projects with tight timelines Why Join Us Long-term contract running through December 2027 $52

•$60/hour for your quality engineering expertise Hybrid schedule with a predictable Monday

•Friday daytime shift High-visibility compliance work on products that support patient care Dedicated recruiter support from Eastridge throughout your assignment

Benefits:

Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements.

Use this link https:

//applicantcenterstorage.blob.core.windows.net/public-documents/EWSb1cb390e-729b-47eb-ab2f-b92adafbdd07-2024EplicaBenefitSummaryTempExternal.pdf to learn more about benefits available to Eastridge's temporary employees. Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions' Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based. However, from time to time Eastridge's clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Disclaimer:

The compensation and benefits information in this posting represents Eastridge's good faith and reasonable estimate of what it might pay for this position. Eastridge reserves the right to modify this information at any time, subject to applicable law.

Equal Opportunity Employer:

Eastridge Workforce Solutions is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity, and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, gender expression, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Eastridge Workforce Solutions also prohibits harassment or retaliation of applicants or employees based on any of these protected categories. It is our policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Background Checks:

Certain clients require Eastridge Workforce Solutions to perform background checks. Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the California Fair Chance Act, the Los Angeles City Fair Chance Ordinance, Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance.

Massachusetts Candidates:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Privacy:

Information collected and processed as part of your candidate profile, job application, resume, and/or any other information you choose to submit is subject to

Eastridge's Privacy Policy:

https://www.eastridge.com/privacy-policy, as well as

Eastridge's Pre-Use Notice of Collection and Automated Decision-Making Technologies:

https://www.eastridge.com/data-collection-notice. By applying for this position, you consent to being contacted by Eastridge Workforce Solutions and its agents or authorized service providers regarding employment opportunities, assignments, and the recruiting process. Communications may be by phone call, AI-assisted or AI-generated phone call (where permitted by law), automated text message (SMS), or email. The purposes for these communications may include, but are not limited to, confirming your interest in available opportunities, scheduling interviews, conducting initial screening conversations, and collecting information relevant to your application. Message frequency may vary. Standard message and data rates may apply depending on your mobile carrier. You may opt out of receiving text messages at any time by replying "STOP" to any SMS message. For additional information regarding our text messaging practices, please review our SMS Terms and Conditions at: https://www.eastridge.com/sms-terms-and-conditions. You may opt out of receiving e-mail by clicking the "Unsubscribe" button. #

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