![TekWissen LLC](https://media.trabajo.org/img/noimg.jpg)
Manufacturing Quality Engineer III
1 month ago
Overview
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Manufacturing Quality Engineer III
Location: Chelmsford, MA, 01824
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday to Friday 8.00 am to 5.00pm
Job Description
- As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert.
- You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective problem resolutions.
- You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall site improvement efforts.
Essential Functions:
- Investigate process/product deviations and out of specification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys etc.
- Ensure DEA compliance and act as a CSP coordinator
- Handle customer complaints with professionalism and efficacy.
- Troubleshoot electrodes and buffer solutions.
- Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances. Verify effectiveness of implemented changes utilizing the proper quality tools.
- Provide guidance for the disposition of non-conforming material (final product and raw material).
- Perform statistical analysis to monitor process and product performance and react to negative trends.
- Lead change controls for complex improvement projects utilizing risk-based methodologies.
- Have an expert level knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma and control plans.
- Lead and participate in generating risk assessments (product and process- FMEAs).
- Have strong knowledge of process, product and equipment validation principles (i.e IQ/OQ/PQ..etc). This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.
- Maintain the site's Quality Systems' conformance to ISO standards and regulatory requirements and policies.
- Drives for continuous improvements in all areas and support improvements efforts, implement changes, and verifies effectiveness of changes.
- Support internal and external audits, customer audits, supplier audits.
- Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
- Write or revise standard quality control operating procedure and quality system documentation as required.
- Write technical reports such investigation summary reports and change management records.
Requirements Knowledge - Skills:
- Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline. Graduate degree (MS) also a plus.
- A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site.
- Proven experience with titrators and PH testing
- Strong verbal and written communications skills in English.
- Ability in technical and statistical writing.
- Must have experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA
- Ability to work in a matrix organization.
- A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
- Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
- Strong analytical, problem resolution, judgment and decision-making skills
- Operation requires the use of safety equipment to include but not limited to safety glasses and safety gloves.
- Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions.
- Prior experience with the release and disposition of nonconforming product through the application of risk assessment and root cause analysis tools.
- Demonstrated validation proficiency, with knowledge of product, process and equipment qualifications and validations (IQ/OQ/PQ).
- Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
- Lean Sigma Green or Black Belt certified a plus.
- ASQ CQE a plus.
- Excellent organization skills with strong attention to details.
- Ability to multitask efficiently to support production demand.
Computer skills:
- Knowledge of Microsoft Office applications (Word, Excel and PowerPoint) is a must.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
-
Manufacturing Quality Engineer III
2 weeks ago
Chelmsford, United States Umanist Staffing LLC Full timeJob DescriptionJob DescriptionDuration:& 12 MonthsJob Type:& Contract Work Type:& OnsiteShift:& & & & & & & & & & & & & Monday to Friday 8.00 am to 5.00pm& & & & & & Job Description & As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert.& You will make an...
-
Manufacturing Quality Engineer
12 hours ago
Chelmsford, Massachusetts, United States Teleflex Full timeJob SummaryThe Quality Engineer II will be responsible for ensuring the quality of all Teleflex products and processes, with a focus on manufacturing activities. This role will contribute to the improvement of the Quality Management System in several key areas, including CAPA and Nonconformance Processes, Incoming Inspection Improvements, Perpetual Audit...
-
Chelmsford, United States Niktor LLC Full timeJob DescriptionJob DescriptionJob Title: Quality Engineer IIIDuration: 12 MonthsLocation: Chelmsford, MA 01824Shift: Monday - Friday 8:00am - 5:00pmPay Rate: $34.00 - $35.00/hr.Job Summary:As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert. You will make...
-
Quality Assurance Specialist III
4 days ago
Chelmsford, Massachusetts, United States Akraya Inc. Full timePosition Title: Quality Engineer IIIJob Overview:We are in search of a seasoned Quality Engineer to spearhead our quality assurance initiatives within the life sciences sector. This role is essential for ensuring that our products and processes adhere to the highest standards of compliance and quality.Key Responsibilities:Lead comprehensive investigations...
-
Quality Engineer
1 month ago
Chelmsford, United States Michael Page Full timeJoin a Privately Owned Company with Outstanding Financial Stability & Security Generous Benefits: Health (all), EAP, 401K, Short & Long Term Disability, Etc About Our Client Our client is a global provider of complex electronic manufacturing services, specializing in printed circuit board assembly, system integration, configuration, and direct fulfillment....
-
Chelmsford, United States V R Della Infotech Inc Full timeJob DescriptionJob DescriptionJob Description: Job Summary:As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert. You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective...
-
Manufacturing Quality Specialist
13 hours ago
Chelmsford, Massachusetts, United States Lockheed Martin Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Quality Engineer to join our team at Lockheed Martin Missiles and Fire Control in Chelmsford, MA. As a Quality Engineer, you will play a critical role in ensuring the highest level of quality in our manufacturing operations.Key ResponsibilitiesReview and develop quality standards, methods,...
-
Senior Quality Assurance Engineer
1 week ago
Chelmsford, Massachusetts, United States Akraya Inc. Full timePosition: Quality Engineer IIIContract Type: W2 OnlyLocation: OnsiteCompensation: $30 - $34 Per HourJOB RESPONSIBILITIES:We are looking for a skilled Quality Engineer with a robust background in life sciences to spearhead our quality engineering initiatives. The selected candidate will play a crucial role in ensuring product and process compliance at the...
-
Manufacturing Quality Assurance Specialist
1 week ago
Chelmsford, Massachusetts, United States Pace Industries Full timeAt Pace Industries, we pride ourselves on fostering a workplace where employees enjoy long-term careers. Our commitment to becoming the leading die casting manufacturer and engineering solutions provider globally is unwavering. Are you ready to contribute to this mission?Position Overview:The Manufacturing Quality Assurance Specialist is essential in...
-
Quality Engineer
1 month ago
Chelmsford, Massachusetts, United States Michael Page Full timeJoin a Privately Owned Company with Outstanding Financial Stability & Security Generous Benefits: Health (all), EAP, 401K, Short & Long Term Disability, Etc About Our Client Our client is a global provider of complex electronic manufacturing services, specializing in printed circuit board assembly, system integration, configuration, and direct fulfillment....
-
Manufacturing Quality Assurance Specialist
4 days ago
Chelmsford, Massachusetts, United States The FootBridge Companies Full timeJob Summary:The FootBridge Companies is seeking a highly skilled Manufacturing Quality Assurance Specialist to join our team. As a key member of our production team, you will be responsible for ensuring the quality and integrity of our products.Key Responsibilities:Quality Assurance: Conduct regular quality audits and inspections to ensure compliance with...
-
Quality Engineer II
3 months ago
Chelmsford, United States Teleflex Full timePosition Summary The Quality Engineer II will be responsible for cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all Teleflex products and processes with a focus on manufacturing activities. In support of Corporate Quality Objectives, the incumbent will contribute, manage, and drive...
-
Manufacturing Engineer
2 months ago
Chelmsford, United States NESC Staffing Full timeManufacturing Engineer We are looking for a local candidates only, no relocation is available.Due to the nature of your business , US Citizenship or Permanent Residency is required.Responsible for all electronic manufacturing engineering development and implementation for productionequipment such as circuit card assemblies, backplanes, cables, and...
-
Manufacturing Engineer
2 months ago
Chelmsford, United States NESC Staffing Full timeResponsible for all electronic manufacturing engineering development and implementation for productionequipment such as circuit card assemblies, backplanes, cables, and harnesses.Develops cost estimates for circuit card assemblies, backplanes, cables, and harnesses. Standard labor time and costed bills of materials by evaluating the customer’s...
-
Manufacturing Engineer
2 months ago
Chelmsford, United States NESC Staffing Full timeResponsible for all electronic manufacturing engineering development and implementation for productionequipment such as circuit card assemblies, backplanes, cables, and harnesses.Develops cost estimates for circuit card assemblies, backplanes, cables, and harnesses. Standard labor time and costed bills of materials by evaluating the customer’s...
-
Electronics Quality Assurance Engineer
1 week ago
Chelmsford, Massachusetts, United States Michael Page Full timePosition OverviewThe Electronics Quality Assurance Engineer plays a crucial role in enhancing and maintaining the performance of processes, products, and components within the electronic manufacturing sector. This position is responsible for crafting quality strategies and overseeing the performance of the supply chain. Additionally, it provides engineering...
-
Electronics Quality Assurance Engineer
1 week ago
Chelmsford, Massachusetts, United States Michael Page Full timePosition OverviewThe Electronics Quality Assurance Engineer plays a crucial role in enhancing and maintaining the performance of processes, products, and components within the electronic manufacturing sector. This position involves the formulation of quality strategies and the oversight of supplier performance. Additionally, the engineer will provide...
-
Manufacturing Process Engineer
1 month ago
Chelmsford, United States The Davis Companies Full timeManufacturing Process Engineer for ITAR facility- MUST BE US Citizen Salary $80-120K DOEMust Have Metal industry and extrusion. AEROSPACE and DEFENSE Industry NO C2C pleaseManufacturing Process Engineer for a motivated client with AS9100 experience. Experience with Deep Drawing, Metal Spinning, Flow forming, or any other coldworking process.Minimum five...
-
Manufacturing Engineer
15 hours ago
Chelmsford, Massachusetts, United States Lockheed Martin Corporation Full timeAbout the RoleThis is a challenging and rewarding opportunity to join the Lockheed Martin Corporation as a Manufacturing Engineer - Microwave Hybrid Specialist. As a key member of our team, you will be responsible for designing and implementing manufacturing processes for advanced technology products.Key ResponsibilitiesDesign and implement manufacturing...
-
Electronics Quality Assurance Engineer
4 days ago
Chelmsford, Massachusetts, United States Michael Page Full timeAbout the CompanyOur client is a leading global provider specializing in intricate electronic manufacturing services, focusing on printed circuit board assembly, system integration, and direct fulfillment. They serve sectors that demand high quality and reliability, including healthcare and military. With operations across multiple locations, they are...