NEOTech · 15 hours ago
Quality Engineer II
Westborough, MA
Full-time
Onsite
Mid Level
$72K/yr - $90K/yr
4+ years expNeotech is a company focused on maintaining a safe and quality-oriented work environment, and they are seeking a Quality Engineer to provide experienced quality assurance support. The role involves managing quality processes, ensuring compliance with quality standards, and leading cross-functional teams for continuous improvement.
ElectronicsManufacturing
No H1B
U.S. Citizen Only
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
Qualification
Required
Knowledge of ISO 9001, ISO13485, FDA-Registration, 21CFR820, and AS 9100
Excellent organizational skills and attention to detail
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
Ability to interpret all customer documents and related specifications
Proficient with Microsoft Office Suite or related software
Minimum AS/AA degree
4+ years of related experience required in a quality organization working preferably within a manufacturing environment
Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C.1324b(a)(3)
Preferred
Bachelor's Degree preferred
Certified as IPC-A-610 CIS or CIT preferred
Knowledge of lean and six sigma methodologies preferred
Benefits
Comprehensive benefit package including medical, dental and vision coverage
Company-paid basic life/AD&D insurance
Short-term and long-term disability insurance
Voluntary supplemental insurances
Flexible spending accounts
Employee assistance program (EAP)
Sick Leave
Vacation Time
Company-paid Holidays
401(k) Retirement Savings Plan option with a company match
Company
NEOTech
NEOTech is a premier provider of electronic manufacturing services (EMS), integrated design engineering, and advanced supply chain solutions for the aerospace and defense, medical device, and high-tech industrial markets.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2013-10-08Acquired
Leadership Team
Kunal Sharma
President & Chief operating officer
Lana McCoy
Human Resources Business Partner
Company data provided by crunchbase