Quality Engineer

Our client is seeking a well-versed Quality Engineer to add to their growing team!

Summary:

The Quality Engineer is responsible for providing experienced quality assurance to support production, internal and external customers, interacting with other departments, suppliers, and customers on technical and quality matters for process improvement. Responsible for maintenance, improvement, and compliance to the Quality Management System (QMS) to meet customer requirements, regulatory and compliance requirements, quality standards, company goals and objectives.

Essential Duties and Responsibilities:

• Support production and quality team in quality and process control for prototype, NPI, and sustaining products through quality control plan of front end (PCBA) and back end (Box Build). Created the quality checklist for inspection.
• Use quality tools to analyze quality data and conduct a periodic quality meeting with internal team and customer for process improvement.
• Lead cross-functional problem-solving team and implement quality tools & techniques to overcome barriers to continuous quality improvements.
• Continually looks for improvement and makes appropriate recommendation.
• Manage DMR, MRB, RMA, and CAPA processes to ensure they are compliant with company procedures.
• Oversee the Corrective Action/Preventative Action (CAPA) process. Initiate CAR/8D to internal team or supplier and follow up until it is closed.
• Review customer data for quality clauses and conformity and respond to customer quality feedback.
• Support incoming inspection and provide the guidance for MSA & AQL.
• Perform risk assessment for quality process including FMEA.
• Work with process engineer and other team for product & process validation (IQ, OQ, PQ).
• Support equipment calibration and maintenance to it is compliant to customer requirements, FDA regulations and ISO specifications.
• Ensure the production floor is compliant with company ESD procedure or ANSI/ESD 20.20 standard.
• Create and maintain QMS documentation to meet the company, regulatory and compliance requirements.
• Schedule, plan, and perform annual internal audits for ISO 9001, ISO 13485, FDA, and AS 9100. Generate the internal audit reports.
• Issue Quality Alert and participate in Purge process.
• Ensure that all production critical supplier issues are resolved in a timely manner, and corrective actions are implemented correctly.
• Monitor and drive PPM issues with the supply base in addition to helping them achieve “Dock to Stock” in accordance to the vendor performance system. Audit supplier as needed.
• Support all corporate and site 6S objectives.
• Perform all other duties, as assigned.
• Establish a collaborative working relationship with all departments. Maintain company quality and ethical standards.

Job Knowledge, Skills & Abilities:

• Excellent organizational skills and attention to detail.
• Knowledge of ISO 9001, ISO
  13485, FDA-Registration, 21
  
  CFR
  820, and AS 9100
• Extensive knowledge of or the ability to quickly learn production processes.
• Deep understanding of PCBA process.
• Experience of dealing directly with customers regarding quality issues.
• Experience in a PCBA low volume high mix or PCBA NPI desired.
• Knowledge of IPC-DVD-64C Component Identification.
• Certified as IPC-A-610 CIS or CIT preferred.
• Understanding of IPC-A-620 and J-STD-001 requirements.
• Ability to interpret all customer documents and related specifications.
• Proficient with Microsoft Office Suite or related software.

Experience/Education:

• Minimum AS/AA degree. Bachelor’s Degree preferred.
• 4+ years of related experience required in a quality organization working preferably within a manufacturing environment.
• Knowledge of lean and six sigma methodologies preferred.

Basic Qualifications:

• Must have proof of U.S. Citizenship to be considered
• Will not be considered if not located within an hour commute of Westborough MA