Quality Specialist/Quality Engineer
3 weeks ago
Support all aspects of quality activities within the organization as directed by the Director of QA/RA. Ensure that the requirements of the Quality System are implemented and maintained, and promote awareness of regulatory and customer requirements throughout the company.
Educational Requirements: Bachelors Degree
Experience Requirements: 3-6 years Quality Engineering experience, and at least 2 years in Medical Device. Auditing experience preferred.
Primary Job Responsibilities:
1. Develop and implement quality management system, strategy and plans to ensure compliance with FDA QSR, ISO 13485, MDD 93/42/EEC and other regulatory requirements in accordance with company goals.
2. Support the Management Representative by interacting and co-operating with government and regulatory bodies (eg BSI, FDA, etc), as necessary, during audits.
3. Monitor performance (in relevant areas) according to appropriate standards and take necessary action to communicate/advise/assist according to performance levels.
4. Monitor and inform/communicate/apply standards created/maintained by external bodies, and integrate within internal quality management systems.
5. Report as necessary on changes in standards (internally and externally initiated) and on performance against standards.
6. Interact with customers and suppliers where necessary (where impacting/affected by quality issues)
7. Support with the preparation of data for Management Review meetings.
Secondary Job Responsibilities:
1. Coordinate the following: Corrective and Preventive Actions (CAPA), Non-conforming Material (NCMR)
2. Participate in Supplier Control activities
3. Coordinate internal and supplier audits. Conduct supplier audits.
4. Coordinate Customer Complaint and Product Surveillance activities including ensuring appropriate notification to customers and regulatory authorities. Complete complaint investigations in eQMS.
5. Lead the quality functions for new product development, design transfer and manage the completion of the design history file.
6. Create and manage a system that ensures the quality of outsourced products and services.
7. Coordinate the Risk Management System.
8. Coordinate computer system validation efforts within the organization, including the drafting of Quality plans and PQs, executing scripts, and drafting reports.
Company DescriptionExtremity Medical is an orthopedic implant and instrument company focused on fusion and motion preservation in the foot and ankle, and hand and wrist. The company sells approximately 15 product lines both in the US and internationally. The company is focused on development of novel products to meet customer needs.Company DescriptionExtremity Medical is an orthopedic implant and instrument company focused on fusion and motion preservation in the foot and ankle, and hand and wrist. The company sells approximately 15 product lines both in the US and internationally. The company is focused on development of novel products to meet customer needs.-
Quality Assurance Specialist
2 weeks ago
Parsippany, United States Insight Global Full timeInsight Global is looking for a Quality Assurance Specialist to join the quality team of one of our pharmaceutical clients. This position will be five days a week on site in Parsippany NJ. AS a QA Specialist you will be responsible for shop floor monitoring, clearance, and record review during aspect of parenteral manufacturing. This individual will perform...
-
Quality Assurance Specialist
2 weeks ago
Parsippany, United States Insight Global Full timeInsight Global is looking for a Quality Assurance Specialist to join the quality team of one of our pharmaceutical clients. This position will be five days a week on site in Parsippany NJ. AS a QA Specialist you will be responsible for shop floor monitoring, clearance, and record review during aspect of parenteral manufacturing. This individual will perform...
-
Parsippany, United States Clinical Dynamix Full timeIf you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of infections, then this top tier company might be the right place for you. We strive to offer a dynamic work environment in which innovation, teamwork, knowledge, and flexibility are valued.The company's novel antibiotics...
-
Associate, Quality Assurance
24 hours ago
Parsippany, United States Ferring Pharmaceuticals Inc. Full timeAs a privately- owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective tha Quality Assurance, Associate, Quality, Assurance, Compensation, Benefits, Technology
-
Quality Control Inspector
4 weeks ago
Parsippany, United States Insight Global Full timeMust-haves Ability to pass a vision test. GMP experience Ability to visually discern product specifications across multiple products. Ability to independently gown for aseptic processing. Day-to-Day Insight Global is looking for three Visual Inspectors to join the one of our large pharmaceutical clients. This position will be 5 days a week onsite, in...
-
Quality Control Inspector
4 weeks ago
Parsippany, United States Insight Global Full timeMust-haves Ability to pass a vision test. GMP experience Ability to visually discern product specifications across multiple products. Ability to independently gown for aseptic processing. Day-to-Day Insight Global is looking for three Visual Inspectors to join the one of our large pharmaceutical clients. This position will be 5 days a week onsite, in...
-
Validation Specialist
2 weeks ago
Parsippany, United States Ferring Pharmaceuticals Full timeDay to Day:Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...
-
Validation Specialist
5 days ago
Parsippany, United States Ferring Pharmaceuticals Inc. Full timeDay to Day: Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...
-
Validation Specialist
2 weeks ago
Parsippany, United States Ferring Pharmaceuticals Full timeDay to Day:Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...
-
Quality Control Lab Manager
1 week ago
Parsippany, NJ, United States Solomon Page Group Full timeOur client is looking to fill the role of Quality Control Lab Manager. This position will be located in the greater Philadelphia area.Responsibilities:Staff management responsibilities include oversight of QC staff.Maintenance of the Environmental Monitoring Program.Lab equipment maintenance and external lab vendors providing materials and services.Author...
-
Hazmat Specialist
14 hours ago
Parsippany, United States Langan Full timeLangan provides expert land development engineering and environmental consulting services for major developers, renewable energy producers, energy companies, corporations, healthcare systems, colleges/universities, and large infrastructure programs throughout the U.S. and around the world. Our employees collaborate seamlessly among 30+ offices and gain...
-
Image Analysis Research Specialist
24 hours ago
Parsippany, United States canfield scientific Full timeThe ideal candidate for our Image Analysis Research Specialist position is an individual with interest in 2D and 3D clinical research and image analysis who performs productively in a fast-paced work environment. The right candidate will possess strong organizational skills, communicate well, and take ownership of and demonstrate responsibility for assigned...
-
Quality Control Inspector
3 weeks ago
Parsippany-Troy Hills, United States Insight Global Full timeMust-haves Ability to pass a vision test. GMP experience Ability to visually discern product specifications across multiple products. Ability to independently gown for aseptic processing. Day-to-Day Insight Global is looking for three Visual Inspectors to join the one of our large pharmaceutical clients. This position will be 5 days a week onsite, in...
-
Validation Specialist
2 days ago
Parsippany-Troy Hills, United States Ferring Pharmaceuticals Full timeDay to Day:Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have...
-
Senior Validation Engineer
7 days ago
Parsippany, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision. Equipment Qualification / Re-Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities. Cleaning Verification / Validation studies for transferred products. Media...
-
Small Group Implementation Specialist
6 days ago
Parsippany, United States Delta Dental of NJ Full timeDelta Dental of New Jersey is currently seeking a Small Group Implementation Specialist to join our sales team. Located in Parsippany, NJ, this is a hybrid position, in office Tuesday and Wednesday, and remote Monday, Thursday and Friday. Beginning in January 2025, we will be in office Tuesday, Wednesday and Thursday, and remote Monday and Friday. Our core...
-
Turbine Module Design Engineer
2 weeks ago
Parsippany, United States Petroplan Full timeThe Turbine Module Design Engineers with a Design Focus are component owners of hardware to be designed or modified;Job Duties:Responsibility for all aspects of design - mechanical design, model/drawing definition, creating a bill of materials and releasing into PLM, supporting hardware procurement and manufacturing /assembly support.Work with Drafting,...
-
Turbine Module Design Engineer
2 weeks ago
Parsippany, United States Petroplan Full timeThe Turbine Module Design Engineers with a Design Focus are component owners of hardware to be designed or modified;Job Duties:Responsibility for all aspects of design - mechanical design, model/drawing definition, creating a bill of materials and releasing into PLM, supporting hardware procurement and manufacturing /assembly support.Work with Drafting,...
-
Turbine Module Design Engineer
1 day ago
Parsippany, United States Petroplan Full timeThe Turbine Module Design Engineers with a Design Focus are component owners of hardware to be designed or modified; Job Duties: Responsibility for all aspects of design - mechanical design, model/drawing definition, creating a bill of materials and releasing into PLM, supporting hardware procurement and manufacturing /assembly support. Work with Drafting,...
-
Small Group Implementation Specialist
5 days ago
Parsippany, United States Delta Dental of NJ Full timeJob DescriptionJob DescriptionDelta Dental of New Jersey is currently seeking a Small Group Implementation Specialist to join our sales team. Located in Parsippany, NJ, this is a hybrid position, in office Tuesday and Wednesday, and remote Monday, Thursday and Friday. Beginning in January 2025, we will be in office Tuesday, Wednesday and Thursday, and remote...