Quality Engineer II

Full Time

Medical Device

("Quality Engineer" or "certified quality engineer")

Job Title:  Quality Engineer II

Location: Irvine 92618 CA 92618-3150

Duration: 11 Months (Extendable)

The pay rate is $39 per hour with benefits

Job Description:

Description/Comment: Ensure compliance to quality procedures / processes.

Conduct product quality tests, compliance and process audits.

Evaluate quality performance.

Investigate quality issues and implement corrective actions.

An intermediate position that requires a Bachelor’s degree or 2-5 years of equivalent experience.

Additional Job Details:

Purpose of the Position: To provide quality engineering duties associated with product support of design or process changes, Remediating and Sustaining Risk Management Files for current products, Monitoring Inspection and Testing Process, Establishing and Maintaining Appropriate Manufacturing Process Validation Files and Change Management related manufacturing Process Controls.

The Senior Quality Engineer will deliver the highest quality product that consistently meets customers and regulatory requirements.

Responsibilities (fundamental job duties):

Primary responsibilities include 1. Ensures that the identification of potential risks and failure modes and the appropriate risk controls mitigation measures implementation on design or process changes.

Revises the appropriate product risk documentation including Design and Process FMEAs and maintains Risk Management deliverables

2. Applies sound, systematic problem-solving methodologies in identifying prioritizing, communicating and resolving quality issues.

3. Performs investigations, analysis of complaints, deviations, and supplier quality assessments to ensure these are conducted in a proper and timely manner.

4. Performs complaint analysis, investigations, review and approval of deviations.

5. Collects and analyzes data to make data-driven recommendations and/or decisions.

6. Ensures process and lab equipment and utility changes are appropriately evaluated, commissioned and validated. Utilizes a risk-based approach to define validation approach and acceptance criteria.

7. Understands and applies the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard, gaging applications, computer-based inspection methods, operator work instruction.

8. Works with manufacturing sites to resolve conflicts and recommends revisions as required.

9. Reviews and approve engineering change requests. Supports and oversee the review and approval of NC’s & CAPAs related to design and process changes

10. Assists with the management of Quality System elements to lead improvement changes using Kaizen, Simple Problem Solving or other continuous improvement tools.

11. Provides support to other Global Quality projects as needed.

Thanks & Regards,

Jatin Anand
Sr. Recruiter

E :

O: +1 470 372 1639

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