Quality Engineer

HCLTech is looking for a highly talented and self‑motivated NPD Quality Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: NPD Quality Engineer

Job : 109083

Position Type: Full‑time with HCLTech

Location: Irvine, CA

The main role of this job opportunity is to provide overall quality assurance support in the execution of select New Product Development project or legacy product engaged in the development or sustenance of Johnson and Johnson Electrophysiology medical device products. Performs ongoing execution of and provides guidance to good manufacturing practices, compliance to internal and external policies and other applicable standards.

Duties include but are not limited to:

• Provides product team support for multitude of new product development activities (e.g., engineering testing, design and process characterization, and other V&V activities)
• Assists in conducting Quality Assurance documentation reviews and audits as needed
• Support execution of risk management activities
• Support development and execution of relevant process development and validation activities (e.g., IQ/OQ/TMV/APQ)
• Utilizes multifaceted industry and process excellence standards in daily quality operations, including, but not limited to, good manufacturing practices (GMP) and Good Documentation Practices (GDP)
• Assists in addressing product or process issues (internally or externally manufactured) or in investigating customer complaints as needed
• Supports handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Collaborate with cross‑functional teams to achieve project team goals and objectives

Provides overall quality assurance leadership in the management of select New Product Development project or legacy product engaged in the development or sustenance of Johnson and Johnson medical device products. Conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards.

Duties include:

• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
• Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
• Addresses and corrects product and process complaints.
• Reports on contract manufacturer performance metrics and ensures management reviews.
• Oversees audits of all quality system categories to assess compliance to process excellence standards. Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.

• A minimum of a Bachelor’s degree required; preferably in Engineering or related technical field

• A minimum of 5 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• Plastics or Molding expertise
• Knowledge of GD&T (Geometric Dimensioning and Tolerancing)
• Ability to develop and implement Quality standards
• Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices
• Thorough knowledge of leading‑edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
• Demonstrated problem solving skills
• Good understanding of theoretical and practical fundamentals and experimental engineering techniques
• Ability to multi‑task and manage multiple assignments in a timely manner
• Good verbal and written communication skills
• Strong interpersonal and leadership skills
• Strong analytical skills

• Ability to apply project management skills to ensure fulfillment of new product development…