Senior Specialist, Quality Engineering

5 days ago

Philadelphia, United States L3 Harris Full time

Job Description: Sr. Specialist Quality Engineering- QMS : Quality Management Systems Specialist position will conduct activities concerned with the L3Harris Philadelphia, PA site and other sites as-hoc as necessary. Quality Management System in all areas of the ISO 9001:2015 QMS. Under general direction from the site Quality leader this position will take a lead role in quality systems coordination, Internal and External Audit Planning, and QMS Document reviews, updates and management of Command Media documentation in a SharePoint site Essential Responsibilities This position will have responsibilities and perform tasks in the following areas:
Coordination and Administration of the maintenace and migration of the QMS Documentation from existing website & backend file shares to the L3Harris Command Media SharePoint site
Internal audit system management to include CAB support
QMS Document control activities to review, updates and releases
Corrective Action Management via CAPA system
QMS related Training record management
Support maintenance and improvement of the quality system and documentation in support of the site
Updates & Maintains the Quality Records matrix and organizes quality records for electronic archive and transfer to an off-site source where applicable
Supports, reviews and audits purchasing activities for ASL adherence with supplier quality flowdown of quality clauses for outside processing orders for compliance to requirements
Identify internal control issues/exceptions and ensure they are well-defined, root causes analyzed and discussed and agreed with management
Investigates problems and develops disposition and corrective actions for recurring discrepancies of equipment
Manages site corrective action logs and schedules weekly meetings to address outstanding corrective actions
Interface and communicate effectively, both orally and in writing, with personnel
Initiate and follow-up on Internal Corrective Action Reports for the audit program
May support the Material Review Board (MRB) and Corrective Action Board (CAB) as needed for QMS compliance
Assist in defect tracking and evaluation process, including trend evaluation to reduce recurrences. (As directed by the Q.A. Manager)
Assist in the implementation of Procedure Review, cross-reference matrix Parent-child relation development
Uses various process methods and tools excel, SharePoint, eQMS workflows to track procedure updates for approvals
Manages site training matrix and requirements, scheduling and delivering training as required to maintain compliance
Ensures the quality management system and records are kept up to date and conform to ISO 9001:2015, DCMA, and other relevant standards as required.
Executes internal audits competently and with minimal supervision
Measure, monitor and report to leadership while collaborating with functional leads on trends, actions, improvement opportunities and effectiveness of the internal audit process
Perform other Quality Engineering tasks as assigned to support Maritime Power, Philadelphia.

Qualifications:
Bachelor’s Degree and minimum of 6 years relevant experience or 10 years of industry experience in process auditing focused on ISO9001 requirements in an aerospace and defense environment or other regulated industry
Working knowledge and experience working with, auditing to, and managing systems aligned with ISO 9001:2015, ISO 19011, AS9100:2016, etc…
Ability to Assess risk and suggest changes
Capable of preparing and following through with audits of all types and scope.
Ability to work with all levels and functions within the organization
Strong written and verbal communication
MS Office suite of programs
Strong experience as a SharePoint site admin/owner for management for document control
eTQ or other EQMS platform Document Control experience a plus
An understanding of the requirements and ability to conduct quality audits and generate audit reports
Ability to calculate Corrective Action Board CAB Key Process Metrics, and Charts presentation creation
Experience with 8D Problem Solving desired.

Preferred Additional Skills:
Lean Manufacturing
Fluency in Microsoft Applications
Demonstrated skill in documentation and/or technical editing.
Exceptional interpersonal and communication skills, both written and verbal.

  • Senior Quality Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Meet Full time

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to support the development and operations of our commercial-scale cGMP cell therapy manufacturing and laboratory facility. As a key member of our team, you will play a pivotal role in providing quality oversight, collaborating with cross-functional teams, and ensuring systems...

  • Civil Construction Project Inspector

    3 weeks ago

    Philadelphia, Pennsylvania, United States Quality Engineering Solutions, Inc Full time

    Job OverviewWe are seeking a skilled Civil Construction Project Inspector to join our team at Quality Engineering Solutions, Inc. in Pennsylvania. This is an exciting opportunity for individuals with a passion for construction inspection and quality assurance.

  • Senior Quality Assurance Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States Capgemini Full time

    Capgemini is a global leader in consulting and digital transformation. We are looking for an experienced Senior Quality Assurance Specialist to join our team in Philadelphia, PA.We offer a competitive salary of approximately $95,000 - $110,000 per year, depending on experience.About the Role:The Senior Quality Assurance Specialist will be responsible for...

  • Senior Quality Assurance Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job Title: Senior Quality Assurance SpecialistAbout the Role: We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Iovance Biotherapeutics Inc. As a key member of our quality control laboratory, you will be responsible for ensuring the highest standards of quality and compliance in our operations.About the Job: The Senior...

  • Senior Quality Assurance Specialist

    3 days ago

    Philadelphia, Pennsylvania, United States Diverse Lynx Full time

    Job Overview:Diverse Lynx LLC seeks a seasoned Senior Quality Assurance Specialist to join our team as the Senior Quality Assurance Specialist. In this role, you will be responsible for ensuring that products meet required specifications for quality, function, and reliability prior to delivery. Your duties will include working with stakeholders to understand...

  • Civil/Site Senior Engineer

    4 weeks ago

    Philadelphia, United States Colliers Engineering & Design Full time

    OverviewA Civil/Site Senior Engineer is a key member of the Civil/Site design team. A Senior Engineer is responsible for various technical aspects of land development projects including, but not limited to: site feasibility and conceptual planning, detailed grading, drainage designs and profiles, stormwater management, designing Erosion & Sedimentation...

  • Senior Quality Assurance Engineer

    3 days ago

    Philadelphia, Pennsylvania, United States URBN Full time

    Job DescriptionWe are seeking a highly skilled Senior Quality Assurance Engineer to join our Retail Engineering team at URBN. As a key member of our agile development team, you will be responsible for leading testing efforts and collaborating with cross-functional teams to deliver high-quality software solutions.Responsibilities:Create effective test plans...

  • Civil/Site Senior Engineer

    4 weeks ago

    Philadelphia, United States Collier's engineering and design Full time

    Reference #: 9691 Overview A Civil/Site Senior Engineer is a key member of the Civil/Site design team. A Senior Engineer is responsible for various technical aspects of land development projects including, but not limited to: site feasibility and conceptual planning, detailed grading, drainage designs and profiles, stormwater management, designing Erosion &...

  • Senior Civil Engineer

    3 weeks ago

    Philadelphia, Pennsylvania, United States Colliers Engineering & Design Full time

    Overview:A Senior Civil Engineer is a key member of the design team at Colliers Engineering & Design. This role is responsible for various technical aspects of land development projects, including site feasibility and conceptual planning, detailed grading, drainage designs, and stormwater management. The Senior Engineer will work within AutoCAD Civil 3D and...

  • Senior Java Software Engineer

    3 weeks ago

    Philadelphia, Pennsylvania, United States Comcast Full time

    Comcast Technology Career OpportunitiesThe Comcast Technology, Product & Experience organization is a dynamic and innovative team that works at the intersection of media and technology. We are continually developing and delivering products that transform the customer experience.About the Job:This Senior Java Software Engineer - Test Automation Specialist...

  • Senior Quality Assurance Business Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Pyramid Consulting Full time

    Job Title: Senior Quality Assurance Business SpecialistWe are seeking a highly skilled Senior Quality Assurance Business Specialist to join our team at Pyramid Consulting, Inc. in Philadelphia, PA. As a key member of our operations team, you will be responsible for ensuring the highest quality claims processing and customer experience.Salary: $28-$30/hourKey...

  • Senior Mechanical Engineering Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States Inabia Software & Consulting Inc. Full time

    About the RoleWe are seeking a highly skilled Senior Mechanical Engineering Specialist to join our team at Inabia Software & Consulting Inc. in Philadelphia, PA.Job SummaryThis is an exciting opportunity for a mechanical engineer with expertise in CAD or SolidWorks to create 3D layouts of existing lab infrastructure and design rack configurations for...

  • Senior Quality Assurance Supplier Specialist

    2 weeks ago

    Philadelphia, United States Disability Solutions Full time

    Senior Quality Assurance Supplier SpecialistPosition Summary: Catalent is a global, high-growth, private company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States UPS Industrial Services Full time

    We are seeking a Senior Quality Assurance Specialist to join our team at UPS Industrial Services. As a key member of our quality control group, you will be responsible for developing, managing, and continuously improving site quality processes.Job SummaryThis is a senior-level position that requires significant experience in quality assurance, preferably in...

  • Senior Engineer, Quality Operations

    2 weeks ago

    Philadelphia, United States Disability Solutions Full time

    Senior Engineer, Quality OperationsPosition Summary: Catalent is a global, high-growth, private company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.  This 206,878...

  • Quality Engineer

    1 month ago

    Philadelphia, United States Meet Full time

    Quality Assurance Engineering SpecialistAre you looking to play a pivotal role in supporting the development and operations of a commercial-scale cGMP cell therapy manufacturing and laboratory facility? This exciting position offers the opportunity to provide quality oversight, collaborate with cross-functional teams, and ensure systems and equipment meet...

  • Senior Quality Assurance Specialist Lead

    3 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Overview">The Senior Quality Assurance Specialist, Operations Investigations role at Planet Pharma will support the review of deviations, investigations, protocols to support the release of materials and products. This position will ensure compliance to procedures by supporting laboratory investigations and manufacturing deviation reviews.Key...

  • Specialist, Quality Engineering- Supplier Quality

    4 weeks ago

    Philadelphia, United States L3Harris Full time

    Job Title: Specialist, Quality Engineering- Supplier Quality Job Code: 12844 Job Location: Philadelphia, PA Schedule: 9/80 reg (every other Friday off) Job Description: This role is the focal point for both internal and external tactical supplier quality activities in Philadelphia. The SSQES serves as the advocate to the supplier within the business and...

  • Senior Quality Assurance Specialist

    1 month ago

    Philadelphia, United States Planet Pharma Full time

    Overview The Senior Quality Assurance Specialist, Operations Investigations role will support review of deviations, investigations, protocols to support release of materials and products. The Sr. Quality Operations Investigations Specialist will also ensure compliance to procedures by supporting laboratory investigations and manufacturing deviation reviews....

  • Senior Quality Assurance Specialist

    1 month ago

    philadelphia, United States Planet Pharma Full time

    Overview The Senior Quality Assurance Specialist, Operations Investigations role will support review of deviations, investigations, protocols to support release of materials and products. The Sr. Quality Operations Investigations Specialist will also ensure compliance to procedures by supporting laboratory investigations and manufacturing deviation reviews....