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 ID: 109083

Position Type: Full-time with HCLTech

Location: Irvine, CA

Role/Responsibilities:

Quality Engineer II Job Description:

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

Qualifications

Education, Skills & Experience:

• A minimum of a bachelor’s degree required (preferably in Engineering or related technical field); or a minimum of 2 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
• Ability to develop and implement Quality standards
• Thorough knowledge of Quality systems and processes, including GMP and QSR requirements for medical devices
• Knowledge of new product development design controls, and verification and validation (V&V) tools and methodologies
• Demonstrated problem solving skills
• Competent in using basic documentation applications such as MS Office (Word, Excel, Powerpoint, Outlook), Adobe PDF, etc.
• Ability to multi-task and manage multiple assignments in a timely manner
• Good verbal and written communication skills
• Strong analytical skills

Preferred Skills & Experience:

• Ability to apply project management skills to ensure fulfillment of new product development requirements
• Experience working in both an FDA and European regulatory environment
• Expertise in NPD (New Product Development) process and Design/Process Validation
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools
• Six Sigma Green/Black Belt Certified
• Knowledge of GD&T (Geometric Dimensioning and Tolerancing)
• Knowledge of statistical analysis tools such as Minitab is a plus

Senior Quality Engineer Job Description:

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.

Qualifications

Education:

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

Required Skills & Experience:

• 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
• Competent using MS Office (word, excel, power point, outlook, etc.)
• 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

Preferred Skills & Experience:

• Ability to apply project management skills to ensure fulfillment of new product development requirement
• Experience working in both an FDA and European regulatory environment
• Understanding of the NPD (New Product Development) process and Design/Process Validation expertise
• A thorough understanding of GMP/ISO regulations and validation regulations
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools
• Six Sigma Green/Black Belt Certified

Pay and Benefits

Pay Range Minimum: $45.0 per hour

Pay Range Maximum: $48.00 per hour

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcltech.com for investigation.

Compensation and Benefits

A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.