Supplier Quality Engineer medical device

Supplier Quality Engineer

This range is provided by HCLTech. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$38.46/hr - $52.00/hr

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

Job Title:

Supplier Quality Engineer

Job  

Position Type:
Full‑time with HCLTech

We are seeking a highly skilled and detail‑oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands‑on experience in supplier qualification, PPAP documentation, and process validation.

• Qualify suppliers in accordance with company standards.
• Manage and maintain the Approved Supplier List (ASL)
• PPAP Documentation & Execution.
• Manage and release all PPAP deliverables including Control Plans, MSA, PFMEA, FAI, etc., within the document control system.
• Support PPAP execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies.
• Inspection & Test Method Validation.
• Define Receiving Inspection requirements.
• Validate test methods in alignment with internal.
• Cross‑Functional Collaboration.
• Work with cross‑functional teams to develop and implement product acceptance sampling strategies.
• Deploy supplier quality tools such as PFMEA, MSA, control plans for both new and legacy products.
• Technical Support & Quality Assurance.
• Provide technical assistance to suppliers throughout the product/process qualification lifecycle.
• Collaborate with suppliers to address SCAPA/NCR issues in compliance with company standards.

• Bachelor’s degree in engineering or related field.
• Minimum 4+ years of experience in supplier quality engineering within the medical device industry.
• ISO 13485 Certified Talent preferred by client.
• Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans.
• Familiarity with FDA and ISO 13485 standards.
• Excellent communication and problem‑solving skills.
• Ability to work independently and in cross‑functional teams.

Pay Range Minimum: $38.46 per hour

Pay Range Maximum: $52 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  for investigation.

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.

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.