Sr. Design Assurance Engineer
Title: Senior Design Assurance Engineer Location: Marlborough, MA (On-Site) A MA-based company that develops innovative medical device laser solutions is rapidly growing and seeking additional support on their Quality team. They are looking for a Senior Design Assurance Engineer to lead NPD activities from start to finish as they continue to create new products. Responsibilities: Conduct product design control activities for both new and ongoing product development projects. Support risk analysis efforts, including design and process Failure Modes and Effects Analysis (FMEA). Assist with Process/Design Validation and Verification activities, including software validation and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities. Aid Design Engineering in creating Design History and Technical Files. Coordinate with third-party test houses for compliance testing of IPG products. Assist the regulatory department with submissions to the FDA, CE, and other regulatory bodies. Perform other essential duties as assigned. Qualifications: Bachelors degree with 7+ years of experience within medical device Experience working with a product from design to commercialization Expertise with design controls and risk management Must be authorized to work in the US without sponsorship If this sounds interesting, please apply for more information!
Negotiable
Marlborough
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CQV
Job Title: Freelance CQV Engineer Start Date: January 2025 Contract: 12 Months Location: Denmark I am working with a big pharma company and looking for an experienced CQV Engineer to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing systems, utilities, and equipment. The ideal candidate will have 5-10+ years of experience in CQV within Downstream processes and mAb processes, Key Responsibilities: Lead CQV activities for manufacturing systems (HVAC, water, production equipment). Develop and review IQ, OQ, PQ protocols and reports. Collaborate with engineering, quality, and manufacturing teams. Ensure compliance with FDA, EU GMP, and internal SOPs. Troubleshoot CQV issues and implement corrective actions. Maintain cGMP-compliant documentation and conduct risk assessments. Requirements: 5-10+ years in CQV, with experience in Downstream and mAb processes. Strong regulatory knowledge (FDA, EU GMP). Excellent documentation, problem-solving, and team collaboration skills. If you're interested, please share a time to discuss further!
Negotiable
Danmark
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Principal/Sr Principal Quality Engineer
Responsibilities: Oversee design assurance and development tasks for New Product Development, including risk evaluations, engineering studies, feasibility assessments, drawing analysis, and statistical evaluations. Ensure compliance with relevant regulatory frameworks, such as FDA, EU MDR, and ISO standards, across all stages of product development. Create and validate advanced experiments and testing protocols to enhance product design and manufacturing processes based on engineering principles. Identify and address quality and regulatory concerns throughout the product lifecycle, providing detailed analysis and reports prior to product launch. Evaluate and audit suppliers to verify materials and components meet strict quality standards, implementing corrective actions as required to ensure compliance. Qualifications: Bachelor's degree in Engineering or a related field; advanced degree preferred. At least 7 years of quality engineering experience in the medical device industry, ideally in cardiac ablation or structural heart technologies. Expertise in quality assurance, control, and process optimization, with strong proficiency in tools like FMEA, CAPA, SPC, Six Sigma, and Minitab. Strong analytical and problem-solving skills, including experience with root cause analysis and corrective action. Hands-on experience with validation processes (IQ/OQ/PQ), product testing, and statistical methods. Proven success in leading quality initiatives and driving continuous improvement, with a focus on risk management and compliance. Excellent communicator, capable of working effectively with cross-functional teams, suppliers, and regulatory agencies. For any questions please reach out to adam.tizabi@epmscientific.org to learn more about this oppurtunity!
US$130000 - US$170000 per year
Irvine
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Quality Manager
Key Responsibilities Lead and Develop Team: Manage and develop a team of Quality Systems Engineers to ensure high performance and growth. CAPA Program Oversight: Administer and lead the Corrective and Preventive Action (CAPA) program across all MCS sites, ensuring processes are effective and compliant. Regulatory Compliance: Proactively identify opportunities to maintain compliance with internal standards and applicable domestic and international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485. Collaboration with International Sites: Provide influential leadership to international partner sites, driving proactive quality improvements and fostering collaboration. Quality Initiatives: Identify and lead cross-functional quality initiatives to drive improvement across the organization. CAPA Expertise: Serve as a subject matter expert, providing guidance on CAPA systems and ensuring alignment with industry best practices. For any questions please reach out to adam.tizabi@epmscientific.org or call (310)-439-5975
US$135000 - US$160000 per year
San Diego
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Technical Expert - Active Electromedical Devices
ABOUT US We are a European organization recognized as an official Notified Body under Regulation (EU) 2017/745, specializing in verifying the conformity of medical devices with the stringent requirements of the MDR 2017/745 regulation. Our work ensures that medical devices meet the necessary standards for certification and market entry within the European Union. For our expanding Medical Devices Division, we are seeking an experienced professional to join our team as a Lead Auditor for Active Electromedical Devices (MDR 2017/745). PRIMARY RESPONSIBILITIES In this role, you will: Conduct audits of manufacturers and, where necessary, their suppliers. Assess the technical documentation of assigned medical devices to ensure compliance with MDR 2017/745. Oversee certification processes for a diverse portfolio of international manufacturers of active medical devices. QUALIFICATIONS Educational Background A degree or advanced qualification in scientific fields such as biomedical engineering, bioengineering, physics, electrical engineering, or similar disciplines. Professional Experience Candidates should have: Significant experience in the active medical device industry, focusing on design, manufacturing, technical documentation, or testing; OR Extensive experience with Notified Bodies, including evaluation of technical files and audit activities for active medical devices. Language Skills
Negotiable
Italy
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Metrologist II/III
Metrologist II/III Job Summary: Our client is seeking a skilled Metrologist to join their team as an expert in calibration for manufacturing and quality control instruments. In this role, you will handle installation, calibration, maintenance, troubleshooting, and repair of complex laboratory and process instrumentation. You will collaborate with Maintenance, Operations, and Automation teams to ensure compliance with SOPs in a cGMP facility. If you have a passion for precision and enjoy solving technical challenges, this opportunity is for you. Duties and Responsibilities: Calibrate and Certify: Calibrate instruments such as lyophilizers, fillers, RO systems, WFI stills, clean steam generators, autoclaves, CIP systems, and lab equipment. Enhance and Improve: Perform assessments and process improvements to enhance calibration testing methods, ensuring compliance with SOPs and cGMPs. Coordinate and Collaborate: Manage scheduled, new, and emergency calibration activities with vendors on all critical process equipment and lab instrumentation. Document and Maintain: Maintain calibration records and instrument tagging, write SOPs, and serve as the technical lead for calibrations deviation, CAPA, and change control. Investigate and Resolve: Create, investigate, and close QMS records (Deviation, CAPA, Change Control, Process Improvement), and assist in troubleshooting instrumentation issues as needed. Experience and Qualifications: Minimum of 6+ years of related experience preferred. Experience in temperature, pressure, flow (liquid & gas), pH, conductivity, humidity, lab instrumentation controllers, depyrogenation oven, freeze dryer, steam generators, steam boilers, air compressor, vacuum pumps, and lab instrumentation. Knowledge of pharmaceutical manufacturing/lab instrumentation environment. Strong knowledge of Blue Mountain calibration software. Thorough understanding of metrology principles defined in ASNI/NCSL required. Familiarity with FDA, cGMP, SOPs, ASNI/NCSL, and ISO standards. Knowledge of pharmaceutical manufacturing process equipment and lab instrumentation. If you're ready to take your career to the next level and make a significant impact in the pharmaceutical industry, apply now to join our client's team as a Metrologist II/III. Your expertise and dedication will help drive innovation and ensure the highest standards of quality and precision.
US$75000 - US$95000 per year
New Jersey
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QC Chemist - 2nd Shift
We have a current opportunity for a QC Chemist position within the 2nd shift. This opportunity offers a competitive package including an annual 12% target bonus! The hours are Monday-Thursday from 3:30pm to 11:30pm, and Fridays from 1:30pm - 9:30pm. Roles and Responsibilities: Report to QC Management. Perform testing of finished products and raw materials per SOPs and methods. Operate and train on various lab instruments (e.g., HPLC, GC, FTIR). Stay updated with USP, FDA, and regulatory guidelines. Assist in resolving Out of Specification (OOS) results. Train new lab personnel and document training. Follow cGMP documentation guidelines. Maintain a safe working environment and ensure equipment calibration. Complete assigned projects and other duties as needed. Communicate effectively within the team and other departments. Qualifications: Must have Bachelor's degree (BS or BA) in Chemistry or related discipline. 1-5 years of laboratory experience in a cGMP environment. Pharmaceutical and/or Nutraceutical industry experience is preferred. Must have Gas Chromatography (GC) and/or Liquid Chromatography (LC) experience and familiarity. Experience with Empower software is a plus.
Negotiable
Lancaster
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Microbiology Supervisor
Microbiology Supervisor Our team is working with one of the fastest growing pharmaceutical companies in the industry on a dynamic Microbiology Supervisor position to lead their lab operations buildout in New Jersey. Duties and Responsibilities: Lead and Inspire: Supervise the microbiology lab and team, driving daily operations to meet critical deliverables and timelines with excellence. Innovate and Implement: Spearhead the implementation and management of cutting-edge microbiology lab technologies, ensuring compliance with regulatory standards and industry best practices. Investigate and Resolve: Tackle complex lab investigations (Out of Specification), identify root causes, and implement effective corrective actions to maintain high-quality standards. Collaborate and Communicate: Work closely with cross-functional teams in QA, Manufacturing, and Regulatory Affairs to support product release and investigation activities, ensuring seamless operations and continuous improvement. Mentor and Develop: Provide guidance, feedback, and direction to the microbiology team, fostering a culture of collaboration, accountability, and continuous improvement. Experience and Qualifications: Bachelor's degree in Microbiology, Biology, Biochemistry, or related field required Minimum of 5 years of experience in a microbiology laboratory required. Minimum of 2 years of supervisory experience preferred. Thorough experience with compendial testing and regulatory requirements (FDA and cGMP) This is your chance to join a company that is revolutionizing the pharmaceutical industry. If you are passionate about quality engineering and eager to lead a team towards excellence, they want to hear from you. Apply now to be a part of their innovative journey and help deliver groundbreaking healthcare solutions.
Up to US$106000 per year
New Jersey
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Senior Specialist, Quality Systems
Senior Specialist, Quality Systems We are seeking a highly skilled Senior Quality Systems Specialist to join a growing Contract Development and Manufacturing Organization (CDMO). In this role, you will be responsible for managing and enhancing quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. You will lead efforts to develop, implement, and maintain quality systems, including document control, CAPA, change control, and risk management processes. As a senior team member, you will collaborate with cross-functional teams to ensure the effective delivery of quality solutions while supporting continuous improvement initiatives. Key Responsibilities: Oversee the development, implementation, and maintenance of quality systems to ensure compliance with GMP and other regulatory guidelines. Lead the management of CAPA, deviations, and change controls. Provide expertise in quality system processes and procedures, ensuring consistency and compliance across all operations. Support internal and external audits and inspections. Collaborate with manufacturing, regulatory, and other departments to drive quality initiatives and resolve quality-related issues. Analyze data to identify trends, initiate corrective actions, and drive continuous improvement efforts. Qualifications: Bachelor's degree in Life Sciences, Engineering, or related field. 5+ years of experience in a Quality Systems role within the pharmaceutical, biotechnology, or CDMO industries. Strong understanding of FDA regulations, GMP, and industry standards (ISO, ICH). Proven ability to lead quality projects and work cross-functionally in a fast-paced environment.
Negotiable
United States of America
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