Quality Engineer III – Onsite in Westborough, MA

A-established electronics manufacturing company is looking for an experienced Quality Engineer to join their team. 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.

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).
• 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.
• 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.
• 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 accordance to the vendor performance system. Audit supplier as needed.
• Support all corporate and site 6S objectives and perform all other duties, as assigned.

QUALIFICATIONS:

• 5+ years related experience in quality engineering in a manufacturing environment.
• Minimum AS/AA degree. Bachelor’s Degree preferred.
• Knowledge of ISO 9001, ISO13485, FDA-Registration, 21CFR820, and AS 9100
• Deep understanding of PCBA process.
• 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.
• Experience of dealing directly with customers regarding quality issues.
• Ability to interpret all customer documents and related specifications.
• Knowledge of lean and six sigma methodologies preferred.
• Excellent organizational skills and attention to detail.
• Extensive knowledge of or the ability to quickly learn production processes.
• Proficient with Microsoft Office Suite or related software.

CoWorx is an equal opportunity employer dedicated to fostering a diverse and inclusive team. We believe that a varied workforce enhances our business outcomes and contributes to a brighter future for our internal teams, Field Talent, customers, and communities. We are committed to considering all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or veteran status, and we do not discriminate based on disability. If you are a person with a disability and require assistance during the recruitment process, please reach out to us.