Sr. Supplier Quality Manager

Sr. Supplier Quality Manager Job Highlights

Company Profile

Amazon is a multinational technology company that focuses on e-commerce, cloud computing, digital streaming, and artificial intelligence.

Job Profile

The company expects a Supplier Quality Manager (SQM) to be working with a unique and gifted cross-functional team to developing exciting products for our customers. The ideal candidate will have experience developing and managing supplier relations in the areas of medical devices and life sciences.

Educational Qualification

• The prospective candidates should have a Bachelor’s Degree in Chemistry or Mechanical, Electrical or Chemical Engineering program.

Work Experience

• Minimum 10 years of experience in a manufacturing and quality environment.
• 10+ years working experience in managing supplier base quality.
• Experience with mechanical/electrical assemblies, familiar with PCBA, wave soldering, ultrasonic/laser welding types, ICT/functional testing, and medical devices.
• Hands-on experience in poke yoke fixture design, mechanical assembly process setup.

Preferred Qualifications

• Able to use Minitab to perform data analysis and make sound decisions.
• Experience in DFM, DOE, and Hypothesis Testing will be a plus.
• Experience working in a regulated manufacturing environment, governed by FDA cGMP and/or ISO 13485 compliance
• Knowledge/familiarity with the pharmaceutical, biotech, and medical device industries
• Proven track record of taking ownership and successfully delivering results in a fast-paced, dynamic environment
• Strong verbal and written communication skills with demonstrated experience engaging and influencing others o Familiar with plastic molding process, able to tune the molding parameters in supplier side and run DOEs find the best process window.

Duties/Responsibilities

• Develop new suppliers or existing suppliers to improve its reliability and quality. Dive into Sub-tier suppliers for quality review and corrective actions when necessary.
• Engages with an experienced cross-disciplinary staff to conceive, design, and develop innovative medical products. You must be responsive, flexible, and able to succeed within an open collaborative peer environment.
• Identify potential problems in product design, specifications, materials, dive deep; able to drive suppliers to find out root causes and solutions.
• Lead cross-functional team to conduct potential supplier qualification audits in both system and process levels.
• Maintain quality data, i.e. audits, build yield, quality scorecards, as a key input to QBR.
• Maintains knowledge of market trends including rigorous analysis of market drivers, cost structures, and technical improvements.
• Manages the Approved Vendors List (AVL) quality and provides inputs into supplier business review (SBR) for continuous improvement in supplier performance.
• Partner with Global Commodity Managers, engineering, and cross-functional team for qualification of second or multiple sources. Review and approve requests for engineering or production changes.
• Perform pre-audit before NPI starts to review supplier readiness.
• The SQM is a critical part of the development process and is responsible for formulating, communicating, and executing a quality control strategy relative to the respective commodity and device.
• The SQM leads supplier process controls and OQC activities and successfully manages the supplier to ensure that the supply chain is capable of delivering high-quality materials on schedule in a fast-paced dynamic and sometimes ambiguous environment.
• Travel 30% to supplier’s manufacturing sites under COVID safety protocols
• Work closely with Engineering to influence technical design decisions, meet custom product requirements, and reach business objectives.

Skills/Knowledge/Abilities

• Ability to read and interpret engineering documents, able to do stack-up tolerance analysis.
• Strong ability to lead supplier qualification and process validation, supplier development and new project launch, troubleshooting, and quality improvement.
• Familiar with measurements, ability to identify program NUDD, product CTQ, and process CTP.
• Solid understanding of quality tools such as statistical process control, such as Pareto charts/8D problem solving, FMEA, GR&R, FAI, CPK, PPAP, etc.

Employer’s Statement

Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.