Quality Systems Specialist

24 hours ago


Conshohocken, Pennsylvania, United States Extremity Care Full time
Job Summary:

The Quality Systems Engineer is a key member of the Extremity Care team, responsible for ensuring product and quality systems compliance through the development, implementation, and monitoring of appropriate processes, tools, metrics, and goals.

Key Responsibilities:

• Develop and implement quality systems and processes to ensure compliance with regulatory requirements
• Support new product development activities, including Master Validation Plans, PFMEA's, Control Plans, and Procedure development
• Investigate and resolve quality events, including NCs and CAPAs
• Maintain current knowledge of FDA QSR, FDA 21 CFR 1271, ISO 13485, AATB Standards, and DMEPOS requirements
• Analyze inspection and testing processes, mechanisms, and equipment
• Develop and/or review product, process test equipment and/or software validation and qualification protocols
• Oversee product release to ensure safe and effective product distribution to customers
• Maintain hazardous and biohazard waste according to EH&S procedures

Requirements:

• Bachelor's degree in science, engineering, or relevant discipline
• Minimum 3 years of experience working in an FDA or ISO regulated environment
• Supervisory experience or equivalent

What We Offer:

• Opportunity to work with a dynamic team in a fast-paced environment
• Competitive salary and benefits package
• Professional development and growth opportunities

How to Apply:

Interested candidates should submit their resume and cover letter to [insert contact information].

  • Conshohocken, Pennsylvania, United States Sharp Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Sharp Corporation. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.ResponsibilitiesEnsure adherence to and enforcement of Good Manufacturing Practices (GMP) compliance throughout the...


  • Conshohocken, Pennsylvania, United States Sharp Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Sharp Corporation. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements in our contract packaging facility.Key ResponsibilitiesEnforce GMP compliance throughout the...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job SummaryAt Extremity Care, we are seeking a highly detail-oriented and organized Quality Control Specialist to join our team. As a Quality Control Specialist, you will play a critical role in ensuring that all products meet established quality requirements.Key ResponsibilitiesConduct thorough inspections of HCT/P products in accordance with standard...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Job Title: Quality Systems EngineerAt Extremity Care, we are seeking a highly skilled Quality Systems Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the development, implementation, and monitoring of quality systems and processes that meet regulatory requirements.Key Responsibilities:Support new product...


  • Conshohocken, Pennsylvania, United States Tandym Group Full time

    HR Operations Specialist OpportunityA biotechnology company is seeking a skilled HR Operations Specialist to support their growing team.About the Opportunity:Setting: Hybrid (at least 3 days a week in office)Contract Length: 6+ monthsResponsibilities:The HR Operations Specialist will:Provide support within the HR team (generalist functions) and provide...


  • Conshohocken, Pennsylvania, United States Sunrise Systems, Inc. Full time

    Job Title: Process Development EngineerJoin Sunrise Systems, Inc. as a Process Development Engineer and contribute to the development of innovative bioprocessing solutions.About the Role:We are seeking a highly skilled Process Development Engineer to join our team. As a key member of our process development team, you will be responsible for designing,...


  • Conshohocken, Pennsylvania, United States Tandym Group Full time

    Medical IT Systems AnalystA leading pharmaceutical company in Pennsylvania is seeking a skilled Medical IT Systems Analyst to join their Medical Affairs team in the Greater Philadelphia area on a contract basis.Key Responsibilities:Ensure the smooth operation and optimization of Veeva CRM implementations tailored to Medical Affairs activities.Manage user...


  • Conshohocken, Pennsylvania, United States The University of Texas at Arlington Full time

    Job SummaryWe are seeking a highly skilled Irrigation Technician to join our team at The University of Texas at Arlington. As an Irrigation Technician, you will be responsible for designing, installing, repairing, and troubleshooting landscape irrigation systems.Key ResponsibilitiesRepair or replace irrigation valves, controllers, heads, and related...


  • Conshohocken, Pennsylvania, United States Sharp Clinical Services Full time

    Job SummarySharp Clinical Services is seeking a highly skilled QA Inspector to join our team. As a QA Inspector, you will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and performing quality inspections of components, bulk product, work-in-process, and finished goods.Key ResponsibilitiesConduct quality inspections to ensure...


  • Conshohocken, Pennsylvania, United States AmerisourceBergen Drug Corporation Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Supply Chain Vision Systems Specialist to join our team at AmerisourceBergen Drug Corporation. This role will be responsible for supporting the effective use and functionality of the Secure Supply Chain Vision Systems across our network of distribution centers.Key ResponsibilitiesEnsure...


  • Conshohocken, Pennsylvania, United States Jacobs Full time

    About the RoleWe are seeking a highly skilled and experienced Construction Turnover Specialist to join our team at Jacobs. As a Construction Turnover Specialist, you will be responsible for ensuring the completion of project/contract turnover documents to the satisfaction of the client, while coordinating and working with the Client selected 3rd party CQV...

  • Electrical Specialist

    7 hours ago


    Conshohocken, Pennsylvania, United States MA 3 Full time

    Job OpportunityWe are seeking a skilled Electrical Specialist to join our team in Conshohocken, PA. The ideal candidate will have experience in commercial and large-scale residential electrical construction projects.The successful candidate will be responsible for installing, maintaining, and repairing electrical systems, including electrical components, MC...


  • Conshohocken, Pennsylvania, United States Top Stack Full time

    Top Stack Group is seeking a highly skilled IT Quality Assurance Leader to join their team in Conshohocken, Pennsylvania. This is a full-time, salaried hybrid position with a competitive base salary and comprehensive benefits package.About the Role:Develop and implement a comprehensive quality assurance strategy, including policies and procedures for...


  • Conshohocken, Pennsylvania, United States UnitedHealth Group Full time

    Transforming Healthcare for Our CommunitiesAt UnitedHealth Group, we're committed to helping people live healthier lives and making the health system work better for everyone. We believe that everyone deserves the opportunity to live their healthiest life, regardless of their background or circumstances.As a Complex Care Specialist with our Landmark Health...


  • Conshohocken, Pennsylvania, United States Cintas Corporation Full time

    Cintas Corporation **Job Summary:** As a Fire Sprinkler Systems Repair Technician at Cintas Corporation, you will be responsible for servicing, repairing, and maintaining fire sprinkler systems to ensure they are functioning properly. **Key Responsibilities:** * Service and repair fire sprinkler systems to meet prescribed standards * Identify and address...


  • Conshohocken, Pennsylvania, United States Randstad Full time

    Operational Finance Support SpecialistWe are seeking an experienced Operational Finance Support Specialist to join our team in Conshohocken, PA. This role requires strong knowledge of SAP ERP systems and experience in Accounts Payable.Key Responsibilities:Collaborate with the Operational SAP Support team to ensure seamless financial operations.Act as a super...


  • Conshohocken, Pennsylvania, United States Boomi L.P. Full time

    Job Title: Associate Systems Engineer IICompany: Boomi L.P.Job Summary:Boomi L.P. is seeking an Associate Systems Engineer II to join our team. As an Associate Systems Engineer II, you will be responsible for implementing defined solutions and strategies based on analysis done by others on customer business goals, objectives, needs, and existing...


  • Conshohocken, Pennsylvania, United States CareSense Full time

    Job OpportunityWe are seeking a talented and motivated individual to join our team as a Client Implementation Specialist. As a key member of our team, you will play a crucial role in designing, configuring, building, and maintaining systems to support our clients.As a Client Implementation Specialist, you will work closely with our development team to gain...


  • Conshohocken, Pennsylvania, United States Extremity Care Full time

    Senior Payroll SpecialistAt Extremity Care, we are seeking a highly skilled Senior Payroll Specialist to oversee our payroll process and ensure compliance with federal, state, and local regulations. This role requires a strong understanding of payroll regulations, tax laws, and industry standards.Key Responsibilities:Process bi-weekly and monthly payroll for...


  • Conshohocken, Pennsylvania, United States Cintas Corporation Full time

    Cintas Corporation **Job Summary:** As a Fire Alarm Systems Inspector at Cintas Corporation, you will be responsible for ensuring the fire alarm systems are functioning properly and meet the prescribed standards. **Key Responsibilities:** * Conduct regular inspections of fire alarm systems to identify any deficiencies or code violations * Perform system...