Demo

Design Quality Engineer

APN Software Services Inc
Walpole, MA Full Time
POSTED ON 3/18/2025
AVAILABLE BEFORE 4/16/2025

Job Description

Job Description

Quality Engineer 2

This order replaces SIMNJP00075609. Please resubmit them to this order if they're still available and interested.

Position Details :

Work Arrangement : 100% remote, must be in the Eastern Standard Time (EST) or Central Time (CST) zones.

Role Justification :

Reason for Hiring : This is a backfill position for a maternity leave, expected to last 6 months.

Candidate Screening :

Resume Submission : The Pre-Hire team will shortlist up to 25 candidates for the manager's review. Resume submission will be halted once this limit is reached.

Technical Skills :

Essential : Basic proficiency in Microsoft Office.

Trainable : SAP, Azure, DevOps.

Experience :

2 years with a bachelor's degree, or

5 years with an associate's degree,

You can include internships in the quality field.

Desired Soft Skills :

Strong communication skills for effective interaction with internal team members and managers.

Self-driven and proactive, not afraid to ask questions.

Education Requirements :

Minimum : Associate's degree with relevant field experience in a quality role.

Preferred : Bachelor's degree (not mandatory).

Interview Process :

Initial Screening : Phone screening with the manager.

Second Interview : Teams video call (on camera) with the manager and at least one team member.

Compensation : Work Hours :

Standard Hours : 8 AM to 5 PM, with some flexibility in start time.

Team Structure :

Team Size : 6 members, with independent work responsibilities.

Additional Information :

Relevant Experience Fields :

Medical devices

Automotive / airplane industry

FDA-regulated fields

Job Posting ID

SIMNJP00076047

Period

02 / 03 / 2025 to 08 / 29 / 2025

Work Location : 333 Coney St

Walpole

02032

Description :

Position Description :

Specific Requirements

The Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Design Chnage. Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding product design and development activities. Additionally, this role will lead specific quality improvement projects as required to support QT and other business initiatives including, but not limited to audits (internal / external), supplier quality, CAPA, and training.

Major Job Responsibilities

  • Participate as a core team member on various design changes
  • Provide assistance to the engineering partners in the development of design verification and validation testing requirements including protocol development, test methods, acceptance criteria, and statistical plans / techniques;
  • Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC.
  • Support internal and external audit needs while serving as the subject matter expert for Design Quality Assurance

Required Knowledge / Skills, Education, and Experience

2-5 years of experience in a Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes.

Timeclock / Shift

Fieldglass|1

Enter Shift Start and End Time

8-5 EST

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