Current jobs related to Quality Assurance Specialist I - Harleysville, Pennsylvania - Medical Components
-
Senior Quality Assurance Specialist
1 week ago
Harleysville, Pennsylvania, United States Medical Components Full timeJob Title: Senior Quality Assurance SpecialistWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Medical Components. As a key member of our quality team, you will be responsible for ensuring the highest quality standards are met in the development, production, and distribution of our medical devices.Key...
-
Senior Quality Assurance Specialist
2 weeks ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timeJob SummaryWe are seeking a highly experienced Senior Quality Assurance Specialist to join our team at Medical Components, Inc. This is a critical role that requires a strong background in quality assurance, regulatory compliance, and leadership.Key ResponsibilitiesQuality Assurance LeadershipDevelop and implement quality assurance strategies to ensure...
-
Senior Quality Assurance Specialist
2 weeks ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timeJob SummaryWe are seeking a highly experienced Senior Quality Assurance Specialist to join our team at Medical Components, Inc. This is a critical role that requires a strong background in quality assurance, regulatory compliance, and leadership.Key ResponsibilitiesQuality Assurance LeadershipDevelop and implement quality assurance strategies to ensure...
-
Senior Quality Assurance Specialist
2 weeks ago
Harleysville, Pennsylvania, United States Medical Components Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Medical Components. As a key member of our Quality Assurance department, you will play a critical role in ensuring the highest quality standards are met in the development, production, and distribution of our medical devices.Key...
-
Senior Quality Assurance Analyst
4 weeks ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timePosition OverviewThe Senior Quality Assurance Specialist will play a pivotal role in ensuring that our products meet the highest standards of quality and compliance within the medical device industry. This position requires a strong background in quality assurance processes and a thorough understanding of regulatory requirements.Key ResponsibilitiesTraining...
-
Senior Quality Assurance Analyst
4 weeks ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timePosition OverviewThe Senior Quality Assurance Specialist will play a crucial role in ensuring that our products meet the highest standards of quality and compliance. This position involves overseeing quality assurance processes and acting as a key liaison between the Quality Assurance team and various departments, including Engineering and Production.Key...
-
Quality Assurance Engineer
3 weeks ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timeJob OverviewThe Quality Assurance Engineer plays a crucial role in ensuring product excellence through rigorous process validations, audits, and inspections. This position is pivotal in identifying, planning, and executing enhancements to existing products and manufacturing methods, directly impacting safety, quality, and efficiency in production.Key...
-
Quality Assurance Engineer
4 weeks ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timeJob OverviewThe Quality Assurance Engineer plays a pivotal role in ensuring the integrity of our manufacturing processes through rigorous validations, audits, and inspections. This position is tasked with identifying, planning, and executing enhancements to existing products and production methodologies that significantly influence safety, quality, and...
-
Quality Assurance Engineer
3 weeks ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timeJob OverviewThe Quality Assurance Engineer plays a crucial role in maintaining high standards of quality through process validations, audits, and inspections. This position is tasked with identifying, planning, and executing enhancements to existing products and manufacturing workflows that directly influence safety, quality, and operational efficiency,...
-
Quality Control Laboratory Supervisor
4 weeks ago
Harleysville, Pennsylvania, United States Actalent Full timePosition Title: Quality Control Laboratory SupervisorRole Overview: The Quality Control Laboratory Supervisor will oversee the daily functions of the quality control laboratory, ensuring adherence to regulatory standards and upholding quality assurance protocols.Essential Qualifications:Bachelor's Degree in Chemistry or a related fieldExperience in a quality...
-
Medical Device Quality Control Manager
3 days ago
Harleysville, Pennsylvania, United States Medical Components, Inc. Full timeJob Title: Medical Device QC SupervisorMedical Components, Inc. is seeking a highly skilled and experienced Medical Device QC Supervisor to join our team. As a key member of our quality team, you will play a crucial role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.Job Summary:The Medical Device QC...
-
flexHOME Support Specialist
4 weeks ago
Harleysville, Pennsylvania, United States Senior Helpers - Lansdale Full timePosition OverviewSenior Helpers is a distinguished home care organization that is continually expanding, recognized nationally for its in-home support services and celebrated as a "Great Place to Work." At Senior Helpers Lansdale, we prioritize the well-being of our caregivers, fostering a culture of respect, teamwork, and acknowledgment, enabling them to...
-
Marketing and Communications Specialist
3 weeks ago
Harleysville, Pennsylvania, United States Total Performance Physical Therapy Full timeAbout Total Performance Physical TherapyWe are a dynamic and growing physical therapy company dedicated to providing exceptional patient care and community service. Our team is passionate about delivering high-quality services and building strong relationships with our patients, community, and healthcare partners.Job SummaryWe are seeking a highly motivated...
-
Registered Nurse
3 weeks ago
Harleysville, Pennsylvania, United States Peter becker COmmunity Full timeJob SummaryWe are seeking a compassionate and skilled Registered Nurse to join our esteemed Skilled Nursing Team at Peter Becker Community. As a Registered Nurse - Skilled Care Specialist, you will have the opportunity to showcase your expertise and passion for delivering exceptional care to our residents.Key ResponsibilitiesProvide high-quality patient care...
-
Harleysville, Pennsylvania, United States TSS Full timePosition OverviewWe are looking for a dedicated Fabrication Specialist and Maintenance Technician to join our Plant Maintenance Division at TSS. The ideal candidate will possess a strong background in both welding and millwright tasks, including proficiency in stick and MIG welding, as well as pipe and plate fabrication.Key ResponsibilitiesEngage in...
-
Residential Electrical Specialist
2 weeks ago
Harleysville, Pennsylvania, United States Synerfac Full time**Job Summary**At Synerfac, we are seeking a skilled Residential Electrical Specialist to join our team. As a Residential Electrician, you will play a crucial role in delivering exceptional electrical services to our clients.**Key Responsibilities:**Work collaboratively with other tradespeople in a residential setting to ensure seamless project...
-
LPN/Licensed Practical Nurse
3 weeks ago
Harleysville, Pennsylvania, United States Peter Becker Community Full timeAbout the RolePeter Becker Community is seeking a compassionate and skilled LPN/Licensed Practical Nurse to join our dedicated team of caregivers. As a skilled care specialist, you will provide high-quality care to our residents, ensuring their physical, emotional, and social needs are met.Key ResponsibilitiesAdminister medications and treatments as...
-
Manufacturing Specialist
1 week ago
Harleysville, Pennsylvania, United States Kelly Services, Inc. Full timeKelly Services, Inc. - Job Overview **Job Summary:** As a Production Operator at Kelly Services, Inc., you will be responsible for ensuring the efficient production of high-quality products. Your key responsibilities will include: * Pulling orders to determine required products for production * Pulling products from the warehouse and delivering them to...
-
HVAC Project Manager
2 weeks ago
Harleysville, Pennsylvania, United States Fuze HR Solutions Inc. Full timeJob SummaryFuze HR Solutions Inc. is seeking a skilled HVAC Project Manager to join our team. As a key member of our organization, you will be responsible for overseeing the coordination and execution of HVAC projects from start to finish.Key ResponsibilitiesProject Coordination: Develop and implement project plans, ensuring timely completion and adherence...
-
Marketing and Business Development Coordinator
2 weeks ago
Harleysville, Pennsylvania, United States Total Performance Physical Therapy Full timeAbout Total Performance Physical TherapyWe are a dynamic and growing physical therapy company dedicated to providing exceptional patient care and community service. Our team is passionate about delivering high-quality services and building strong relationships with our patients, community, and healthcare partners.Job SummaryWe are seeking a highly motivated...
Quality Assurance Specialist I
3 months ago
- Bachelor's degree in engineering, life sciences, or related field preferred.
Minimum 4-6 years related experience in Quality Assurance within Medical Device or other regulated industry; or equivalent combination of education and experience.
Strong understanding of Medical Device regulations (FDA 21CFR820 and ISO 13485)Experience with quality management systems and associated processes.Quality certifications (e.g ASQ Certified Quality Auditor or Engineer) a plus. Excellent analytical skills, able to solve complex problems and make data-driven decisions. Effective communication and interpersonal skills with the ability to collaborate across functional teams.
What you will be responsible for:
This position is responsible for supporting Quality Assurance processes; including but not limited to corrective/preventive action activities, batch record reviews, and change control, represent associated QA processes during internal and external audits, as needed.
This position serves as QA delegated authority for the disposition of device history records, ensuring documentation is complete, accurate and demonstrates lots are manufactured in accordance with product specifications/requirements.
How you will contribute:
Reviews manufacturing and support records (Device History Records (DHR)) to ensure product specifications are met prior to final product disposition.
Provides final QA disposition of DHR, including release of products based on acceptance of manufacturing and support records.Reviews proposed product and process changes initiated through the Change Review process for accuracy and completeness.
Provides final QA disposition of recommended product and process changes initiated through the Change Review process.
Works with Production and cross-functional teams to resolve issues resulting from record reviews.
Conducts and supports investigation of non-conformances and identification of corrective and preventive actions, as needed.
Develop and implement CAPA plans to address root causes to prevent recurrence.
Serves as a team member for audits, including customer, internal and external (regulatory inspections) by assisting with document retrieval efforts, and other activities related to support a successful outcome.
Acts as a team member in supporting quality disciplines, decisions, and practices.Identify opportunities for process improvements and drive initiatives to enhance quality, efficiency, and effectiveness.
Applies critical thinking, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Generate internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
Performs duties in an ethical and compliant manner, ensuring compliance to Medical Device global regulations, standards and company policies and procedures.
Provide training and support for responsible quality system processes, as needed. Monitor and trend quality processes, initiate actions to resolve negative trend results. Report and escalate trends to management.Perform other job-related duties, as directed. About Us
- Medcomp develops, manufactures, markets, and supports cutting edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis.
Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies.
Our offerings have our Team Members' well-being in mind.Competitive compensationHealth, Dental, Vision coverageFSALife Insurance401kPaid HolidaysGenerous PTOWhat you will get from us:
VISION & MISSION STATEMENTTo be the leading solution provider for every customer we serve.
To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world class products and services.
We offer meaningful rewarding work to our team members by providing a culture that is built on and supported by practicing our core values, and by providing our team members with the tools and resources they need to succeed.
We are committed to ensuring equal employment opportunities for all job applicants and employees.Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
