- 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.
-
Quality Engineer
5 days ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesHello, my name is Daniel, and I am a recruiter with Kelly Services. One of our prominent clients is seeking a Quality Engineer in Westborough, MA. · Responsibilities: · Provide manufacturing and/or engineering process support in accordance with documented procedures and practices ...
-
Quality Engineer
4 days ago
Kelly Services, Inc. Westborough, United States#x 9; Provide manufacturing and/or engineering process support in accordance with documented procedures and practices. Responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Assurance fundame Quality Engineer, Engineer, Q ...
-
Quality Engineer
4 days ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesHello, my name is Daniel, and I am a recruiter with Kelly Services. One of our prominent clients is seeking a Quality Engineer in Westborough, MA. · Responsibilities: · Provide manufacturing and/or engineering process support in accordance with documented procedures and practic ...
-
Quality Engineer
7 hours ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesHello, my name is Daniel, and I am a recruiter with Kelly Services. One of our prominent clients is seeking a Quality Engineer in Westborough, MA. · Responsibilities: · Provide manufacturing and/or engineering process support in accordance with documented procedures and practice ...
-
Quality Engineer
1 week ago
Velocity Solutions North Walpole, United StatesAbout the Company · As a system partner of the office furniture industry, we specialize in the development and production of functional fittings made of metal and plastic. As one of the leading companies in Europe, we strive to quickly and flexibly fulfill individual customer req ...
-
Quality Engineer
5 days ago
Trelleborg Sealing Solutions Northborough, United StatesResponsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control o ...
-
Quality Engineer
20 hours ago
Trelleborg Sealing Solutions Northborough, United StatesResponsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control o ...
-
Quality Engineer
1 week ago
Trelleborg Sealing Solutions Northborough, United StatesResponsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control o ...
-
Quality Engineer
4 days ago
Trelleborg Sealing Solutions Northborough, United StatesResponsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control o ...
-
Manufacturing Quality Engineer
6 days ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesManufacturing Quality Engineer · Location: Onsite - Westborough, Massachusetts · Type: Contract - (NO C2C OR THIRD PARTY) · Pay Rate – Negotiable depending on DIRECT-related experience · Work Authorization - Must be able to work in the U.S. with approved authorization status as ...
-
Quality Engineer
2 weeks ago
Trelleborg Northborough, United StatesQuality Engineer Expectations:Supports internal audit program as necessary. · Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines c ...
-
Manufacturing Quality Engineer
1 day ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesManufacturing Quality Engineer · Location: · Onsite - Westborough, Massachusetts · Type: · Contract - (NO C2C OR THIRD PARTY) · Pay Rate · – Negotiable depending on DIRECT-related experience · Work Authorization · - Must be able to work in the U.S. with approved authorizatio ...
-
Quality Assurance Engineer
20 hours ago
LanceSoft Westborough, United StatesJob Description: · Title: Quality Assurance Engineer · Location: Westborough, MA 01581 · Shift: 1st Shift · Duration: 09 months (Possible Extension) · The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance w ...
-
Quality Engineer II
1 week ago
Laborie Medical Technologies Corp Westborough, United StatesWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like ...
-
Quality Engineer II
1 day ago
Laborie Medical Technologies Corp Westborough, United StatesWe believe that great healthcare is an essential safeguard of human dignity. · At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd l ...
-
Manufacturing Quality Engineer
5 days ago
Kelly Science, Engineering, Technology & Telecom Westborough, United StatesManufacturing Quality Engineer · Location: Onsite - Westborough, Massachusetts · Type: Contract - (NO C2C OR THIRD PARTY) · Pay Rate Negotiable depending on DIRECT-related experience · Work Authorization - Must be able to work in the U.S. with approved authorization status a ...
-
Quality Engineer II
1 day ago
NEO Tech Westborough, United StatesJob Details · Job Location · Westborough 0NK54 - Westborough, MA · Job Category · QA - Quality Control · Description · Summary: · The Quality Engineer is responsible for providing experienced quality assurance to support production, internal and external customers, interacti ...
-
Quality Engineer II
16 hours ago
NEO Tech Westborough, United StatesJob Details · Job Location · Westborough 0NK54 - Westborough, MA · Job Category · QA - Quality Control · Description · Summary: · The Quality Engineer is responsible for providing experienced quality assurance to support production, internal and external customers, interactin ...
-
Quality Engineer
1 day ago
Cognex Corporation Southborough, United StatesAbout us- Cognex is the largest, most successful and recognized global player in industrial machine vision We are a financially strong, international company with no debt and have been in business for over 40 years. Using advanced optics, image sensors and artificial intelligence ...
-
Medical Device Quality Engineer
2 days ago
Talent Groups Westborough, United States5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries. · Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FD ...
Quality Engineer II - Westborough, United States - NEO Tech
Description
Job DetailsJob LocationWestborough 0NK5- Westborough, MAJob CategoryQA - Quality ControlDescriptionSummary: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:
QualificationsJob Knowledge, Skills & Abilities:
Knowledge of ISO 9001, ISO13485, FDA-Registration, 21CFR820, and AS 9100Excellent 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.
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.
Benefits Offered:
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 and employee assistance program (EAP).
Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match.NEOTech is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment.We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers.
We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Company's equipment and facilities.
For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace.Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.