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Quality Assurance Engineer
3 weeks ago
Spectrum Dynamics Manchester, United StatesAbout Voith Group · The Voith Group is a globally operating technology company. With its broad portfolio of systems, products, services, and digital applications, Voith sets standards in the markets of energy, paper, raw materials, and transport & automotive. Founded in 1867, Voi ...
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Quality Engineer
2 weeks ago
Summit Packaging Systems Manchester, United StatesProbeer jij door de ogen van een klant te kijken naar ons eindproduct? Dan zijn wij op zoek naar jou · De afdeling Quality Control speelt bij ons een belangrijke rol als het gaat om kwaliteitscontrole. Als Quality Engineer ben je verantwoordelijk voor de kwaliteitscontrole van ho ...
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Quality Engineer
2 weeks ago
Merrimack Manufacturing Manchester, United StatesMerrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. · We are searching for a Quality Engineer to support manuf ...
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Quality Engineer
2 weeks ago
Merrimack Manufacturing Manchester, United StatesJob Description · Job DescriptionMerrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. · We are searching for a Q ...
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Quality Engineer
3 weeks ago
Tekni-Plex Manchester, United StatesSUMMARY/PURPOSEThis position is responsible for supporting quality engineering activities.This includes participation in the development of new products and processes through commercialization, validation, change management and root cause investigations. Works with various depart ...
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Supplier Quality Engineer
3 weeks ago
DEKA Research & Development Manchester, United StatesThe Supplier Quality Engineer will develop, maintain and support supplier quality assurance efforts to ensure that products and services meet specification requirements for components and assemblies. This role will communicate with suppliers to provide technical input and guidanc ...
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Supplier Quality Engineer
3 weeks ago
DEKA Research & Development Manchester, United StatesThe Supplier Quality Engineer will develop, maintain and support supplier quality assurance efforts to ensure that products and services meet specification requirements for components and assemblies. This role will communicate with suppliers to provide technical input and guidanc ...
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Sr. Quality Engineer
2 weeks ago
Merrimack Manufacturing Manchester, United StatesJob Description · Job DescriptionMerrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. · We are searching for a S ...
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Sr. Quality Engineer
1 week ago
Sanmina SCI Manchester, United StatesCategory (For Job Seekers) · Quality · Location · H3401 - Plant 9 Manchester NH - Manchester, NH 03103 US (Primary) · Job Description · Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global E ...
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Supplier Quality Engineer
2 weeks ago
DEKA Research & Development Manchester, United StatesThe Supplier Quality Engineer will develop, maintain and support supplier quality assurance efforts to ensure that products and services meet specification requirements for components and assemblies. This role will communicate with suppliers to provide technical input and guidanc ...
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Sr. Quality Engineer
2 weeks ago
Sanmina-SCI Manchester, United StatesSanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing ...
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Quality Engineering Technician
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Merrimack Manufacturing Manchester, United StatesJob Description · Job DescriptionMerrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. · We are searching for a Q ...
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Quality Engineer
3 weeks ago
Merrimack Manufacturing Manchester, United StatesMerrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.We are searching for a Quality Engineer to support manufactu ...
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Quality Engineer
3 weeks ago
Tekni-Plex Manchester, United StatesSUMMARY/PURPOSE · This position is responsible for supporting quality engineering activities. · This includes participation in the development of new products and processes through commercialization, validation, change management and root cause investigations. Works with variou ...
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Quality Engineer
1 week ago
Tekni-Plex Manchester, United StatesSUMMARY/PURPOSE · This position is responsible for supporting quality engineering activities. · This includes participation in the development of new products and processes through commercialization, validation, change management and root cause investigations. Works with various ...
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Quality Engineer
3 weeks ago
Sequel Medical Technology Manchester, United StatesAbout Sequel · Sequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare. · ...
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Quality Engineer
2 weeks ago
Merrimack Manufacturing Manchester, United StatesMerrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life. · We are searching for a Quality Engineer to support manuf ...
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Quality Engineer
1 week ago
Manpower Group Inc. Manchester, United StatesOur client, Martinrea, in Manchester is currently seeking a motivated and reliable individual to work as a Quality Engineer This is temporary opportunity that starts immediately. Apply today · Location: Martinrea in Manchester, MI · Compensation: Negotiable - WEEKLY PAY · What ...
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Quality Engineer
5 days ago
Connexion Systems & Engineering, Inc. Manchester, United StatesJob Description · Job DescriptionQuality Engineer - Medical Device · Searching for a Quality Engineer to support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and test of ...
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Quality Engineer
1 week ago
Lockheed Martin Corporation Manchester, United States: Lockheed Martin Missiles and Fire Control (LMMFC) Chelmsford, MA is seeking a motivated and driven Quality Engineer to support our manufacturing operations. · As a recognized designer, developer and manufacturer of precision engagement aerospace and defense systems for the U.S ...
Quality Engineer - Manchester, United States - Sequel Medical Technology
Description
About SequelSequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions.
Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare.
Job Overview
The Quality Engineer will be a key member of our growing Quality/Regulatory team as we build out a robust QMS compliant with FDA and EU regulations.
The QE will first contribute in areas immediately being phased in, including document control system implementation, and Market, Legal and Review documentation and approvals.
Longer-term phase-in will include responsibilities in all areas of QA and Regulatory activities as we build out our systems.Job Responsibilities and Essential Duties
Assist with activities related to controlled documents in the quality management system including document creation, obsolescence, archival, and revisions.
Review documents for accuracy, completeness, and compliance in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820).
As a Documentation Control team member will contribute to supporting the Document Control Manager with implementing Sequel's QMS, MLR process review and approvals, and document control system implementation.
Support and drive advanced data analysis techniques and reporting tools.Support FMEA and Risk Analysis
Provide day-to-day support for Document and Change Control in the electronic QMS
Assist with internal and external audits. Coordinate/track/drive closure of QMS audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner
Support Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
Support analysis of defective components found in Incoming Inspection and work with suppliers to resolve through the SCAR process.Compile and present quality issues and KPI to cross functional teams in a concise and clear manner.
Work independently and within teams.
Travel required up to 20% including some international.
Minimum Requirements
Bachelor's degree in a STEM area or equivalent experience.
Experience as a QE in a medical device manufacturing company.
Project management tracking and trending experience.
Veeva Vault, Veeva Learning, Veeva QMS, Veeva PromoMats preferred.
Required Knowledge, Skills and Abilities
Deep understanding of FDA GMP principles and ISO 13485 requirements
Experienced in the development and execution of validation activities for manufacturing and software. Design verification and validation is a plus.
Experienced in building out elements of a QMS system, including creating quality plans, developing and releasing SOP's, training and process mentoring.
Experienced in the use of data analytics development tools such as Power BI or others.Firmly understands the best practices for driving effective corrective and preventive actions and can mentor others in that process.
Six Sigma experience
Lean manufacturing experience
Advanced statistical data analysis skills
Ability to manage multiple projects and tasks with ease.
Environmental/Safety/Physical Work Conditions
Ensures environmental consciousness and safe practices are exhibited in decisions
Use of computer and telephone equipment and other related office accessories/devices to complete assignments
May work extended hours during peak business cycles
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