Regulatory Affairs Specialist – Medical Devices
Newton Colmore is working with a medical devices company in Cambridge who are looking to hire a regulatory affairs scientist/engineer to join their team.
This role will give you an opportunity to take lead on quality assurance and regulatory affairs matters across this international organisation. Although the role will have a focus on medical devices, it will also provide you with experience of new highly regulated industries.
Because this company conducts R&D and manufacturing across the world you will be working to European, American, and Asian standards and so will give you a varied project scope.
You will be reporting directly to the QA Director and the principal analyst within the team and will be charged with running quality and regulatory focused initiatives within the company and find novel solutions to new and existing problems with projects and management systems.
This company will reward you with a tailored salary and package to suit your expectations, with bonuses, free lunches, and a variety of further benefits. The company pride themselves on their training and development as well as the highly technical nature of their work and so this role could be a great next step for your career.
For more information make a confidential application now and a member of our team will be in touch with more details.
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JOB DESCRIPTION
ESSENTIAL FUNCTIONS:
Perform post-batch activities in a timely manner, efficiently, and with accuracy, including but not limited to the following: Ensure all manufacturing documentation is filled out as required, manufacturing packet is complete, and expediently addressing gaps in data and/or documentation when they arise during post-batch review process. Review of manufacturing data/settings for potential issues and enter manufacturing data into corresponding spreadsheets and/or databases. Scan and index manufacturing packets and records into company document database. End production orders (batch runs) in company ERP system and notify internal teams to address any discrepancies in the ERP system preventing production order from being "Ended" in the system. Lead and conduct objective root cause analysis for internal quality issues as they relate to manufacturing data and/or documentation. Provide on-site technical and Quality assistance to internal departments, as required, including but not limited to: Customer concerns (root cause analysis, testing, and reporting) Internal corrective action requests (root cause analysis and corrective actions) Internal audits (cross departmental and risk-based auditing) Continuous improvement projects. Ensure TCI procedures - Quality Manual, work instructions, forms, flowcharts - and other related documents are maintained, current and up to date. Ensure compliance with all training, procedures, record keeping, and documentation requirements supporting TCI's Quality Management System. Prepare communications, reports, and give technical presentations. Support and/or cover QA team responsibilities during team member absences to ensure process continuity. Ensure and maintain a safe working environment for all employees. Other duties as assigned. Apply for this ad Online!....Read more...
Quality Assurance ManagerLocation: Leeds, LS10Work Schedule: Monday–FridayEmployment: Full-time, PermanentSalary: Circa £50,000 per annumAre you passionate about quality and craftsmanship? Our client a leading UK hospitality furniture manufacturer and is seeking an experienced and proactive Quality Assurance Manager to join their dynamic team. With 135 dedicated staff and a reputation for excellence, they produce high-quality furniture, in their Leeds factory, for clients such as Hilton, Marriott & Radisson.About the RoleAs our Quality Assurance Manager, you will play a key role in upholding and enhancing our product standards across all manufacturing operations. You will lead our quality assurance processes, oversee compliance for all our production, and drive continuous improvement initiatives to ensure our customers receive only the best.Key Responsibilities
Develop, maintain, and continuously improve the Quality Management System in line with customer, regulatory, and company standards.Lead, coach, and develop the Quality Assurance team, promoting a culture of quality, accountability, and continuous improvement.Oversee quality assurance and quality control activities, ensuring all products meet required specifications and customer expectations.Conduct regular audits, inspections, and supplier assessments to ensure adherence to company and regulatory standards.Lead root cause investigations and implement effective corrective and preventative actions (CAPA).Maintain quality documentation and SOPs.Work collaboratively with Production, Engineering, Supply Chain, and other departments to resolve quality issues and drive operational improvements.
About You
Proven experience in a Quality Management role within a manufacturing environmentExcellent communication, leadership, and problem-solving skills.Ability to travel to local supplier sites as required.Experience managing supplier quality and conducting audits.
What We Offer
Competitive salaryCompany pensionOpportunities for training, development, and career growth.Supportive team environmentThe chance to make a real impact within a growing manufacturing business23 days’ annual leave plus statutory holidays
Apply NowIf you are an organised, proactive leader with a passion for operational excellence and delivering outstanding customer service, we’d love to hear from you.Curtis Furniture Ltd is an equal opportunities employer and welcomes applications from all suitably qualified candidates. Quality Assurance Manager, QA Manager, Quality Manager, Quality Control Manager, Manufacturing Quality, Quality Assurance, Quality Control, ISO 9001, CAPA, Continuous Improvement, Supplier Quality, Furniture Manufacturing, Manufacturing, Leeds Jobs, West Yorkshire Jobs. INDLSEquals One is an advertising and recruitment agency working on behalf of our client to promote this vacancy. You may be contacted directly by the employer should they wish to progress your application. Due to the number of applications we receive, we are unable to provide specific feedback if your application is unsuccessful.....Read more...
JOB DESCRIPTION
The QA Technical Service Representative is responsible for the timely delivery of services as they relate to the quality assurance of Tremco's installed roofing systems within their respective region.
Duties/Responsibilities, Core knowledge:
Lead Technician performing roof patch and repair as necessary and determined by the Quality Assurance Group on Tremco Incorporated roof systems (BUR, Modified Bitumen, Single Ply, Fluid Applied, etc.). Estimate material and labor quantities for roof patch and repair. Perform Job Site Inspections as they relate to quality assurance and/or adjustment work. Perform detailed roof inspections to diagnose and troubleshoot issues and/or concerns. Work with local WTI Field Representatives and/or Supervisors as required or necessary. Provide accurate and timely documentation to ensure that all work was completed properly and that the customer is fully satisfied. Conduct and foster professional and timely communication (via email, voicemail, in person) with the customers, sales reps, field staff, and internal company personnel on all work-related matters. Demonstrate working knowledge of all services provided. Perform any other duty and/or project as required or assigned by the QA Assurance Group.
Skills, Qualifications, Experience, Special Physical Requirements:
High school diploma or GED Prior supervisory skills and ability to manage people and tasks Prior roofing experience including patch and repair skills Knowledge and ability to use basic tools associated with commercial roofing Knowledge and experience monitoring and maintaining Quality Control Functional computer skills Safety training and OSHA knowledge with a commitment to safety at all times Understanding and ability to manage expenses Planning and organizational skills. Able to juggle multiple priorities and demonstrate good task management Work independently, as well as in a team environment, to solve problems and delegate assignments Excellent customer service skills and ability to build relationships Ability to climb up and down interior/exterior ladders to access roofs (minimum of 20 ft) and carry basic hand tools, equipment and/or material up to approx. 100 lbs. over long distances Capable of walking along roof top edges (no fear of heights, good balance, etc.) Ability to handle prolonged exposure to outside weather conditions (heat, cold, etc.) Ability to travel out of town including overnight travel Must have transportation and a valid driver's license Ability to work weekends and/or holidays if needed Ability to pass pre-employment drug test Ability to read, write and speak English The hourly rate for applicants in this position generally ranges between $20 and $33. This range is an estimate, based on potential employee qualifications, operations, needs, and other considerations permitted by law. Benefits: Tremco offers a variety of benefits to its employees, including not limited to: health insurance, paid time off, 401(k) with company match, Company Pension Plan, and continuing education. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.
ABOUT US
Tremco Construction Products Group (CPG) brings together Tremco Incorporated's Commercial Sealants & Waterproofing and Roofing & Building Maintenance operating divisions; Dryvit Systems, Inc.; Nudura Inc.; Willseal; Weatherproofing Technologies, Inc. and Weatherproofing Technologies Canada, Inc. Structures with Tremco CPG systems are easier to build and maintain, virtually impervious to the elements, and can provide any look desired. Six-sided solutions from Tremco CPG companies deliver demonstrable performance at the lowest possible life-cycle cost, and stop leaks before they happen through ongoing maintenance programs. Building owners gain the peace of mind that comes with industry-leading system warranties - all from a single source platform.Apply for this ad Online!....Read more...
