What are the responsibilities and job description for the Product Quality Engineer position at VM Services, Inc. (member of the Venture Group of...?
Pay: $85,000.00 - $100,000.00 per year
Job description:
Job Description/Responsibilities:
- Support ISO 9001:2015, AS9001D, ISO 13485:2016 internal audit and implementation.
- Ensure quality related deliverables are met as defined by the product development process and project plans.
- Provide Quality Engineering and Assurance Services and Technical Expertise to support product quality and overall system compliance.
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Work with Manufacturing and Process Engineering to ensure product quality.
- Work with Customer SQEs and other related engineering fields in the completion of Product Qualification Process (PQP) and Production Part Approval Process (PPAP).
- Coordinate and manage the Corrective and Preventive Action system (CAPA).
- Lead Root Cause Investigations efforts using common Root Cause Analysis Methodologies (5 Whys, Fishbone Ishikawa, Pareto Charts, etc.)
- Active involvement in maintaining, reviewing, and reporting Quality Performance Data (KPIs) and opportunities for improvement for management review.
- Evaluate product and process changes to assure compliance with regulatory, corporate, customer, and 3rd party safety requirements (UL, Intertek, CCC, Etc.).
- Participate in MRB/CPI to engage with process and yield improvement
- Monitor RMA return rate and support FA / Process improvement
- Ensuring that the quality management system conforms to the requirements of International Standard.
- Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Job Requirements:
- Bachelor’s Degree in Technical Discipline (Engineering, Math, Science or Equivalent Experience)
- At least 5 years of experience in contract manufacturing in PCBA and Box Build Assembly.
- Extensive knowledge and certified internal auditor in ISO 9001:2015, ISO13485:2016 and AS9100D
- Familiar with DOE, FMEA, PPAP, SPC, PQP, TQM, ISO, Six Sigma
- Knowledge of the basic QA functions i.e. IQA, FQA, MRP, RMA, FAI, QCC, CAPA, SCAR, etc.
- Strong analytical skill and hands-on problem solver with decision making background.
- Strong Knowledge in Microsoft Office (Word, Excel, PowerPoint, Access Database)
- Understand SMT processes and quality requirements
- Good communication and writing skills
- Strong knowledge of PCBA (SMT and PTH) Box-Build and repair (RMA) business a must.
- Must be familiar with medical products requirements.
- Knowledge in IPC, Bellcore, and JEDEC standards.
- Statistical Process Control and / or Six-Sigma capabilities.
- Must be able to work independently with minimum supervision.
Preferred
- Experience in PFMEA and Process Control Plans
- Experience in Eight Disciplines (8D) Problem Solving Methodology
- IPC-A-610 & J-STD-001 CIS or CIT Certification
- ISO9001, ISO13485 and AS9100 Internal Auditor Certification
** This role is not eligible for relocation or remote work **
Pay: $85,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
Salary : $85,000 - $100,000