Job Title: Quality EngineerJob Description Lead quality investigations related to in-the-market defects to identify root cause and implement corrective actions and preventative actions. Collaborate with cross-functional teams to investigate failure modes and execute impact assessments to ensure appropriate countermeasures are developed and launched. Interface with customers and suppliers to address non-conformances identified during manufacturing. Lead process improvement initiatives utilizing Statistical Process Control (SPC) and Six Sigma methodology such as 5S, Value Stream Mapping, Control Plans, PFMEA, and Process Mapping. Lead Manufacturing Quality Assurance aspects of process control, initiating projects to ensure that targeted process flows are effective and achieve operational requirements, and provide guidance to SMEs on root cause and corrective action (RCCA) activities. Recommend process improvements to management and execute to ensure consistent implementation of internal requirements and external regulations and standards. Provide status reporting regarding manufacturing process deliverables, dependencies, risks, and issues, communicating across teams and management. Advise manufacturing and quality teams on the implementation of international standards and regulatory standards as they relate to the manufacturing of product and Good Documentation Practices (GDP). Participate in the investigations and dispositions of product non-conformances and changes, CARs, and MRB. Generate and maintain procedures, work instructions, and forms, as necessary to ensure standardization of practices. Implement required changes to existing training programs and assist in training staff members. Perform other tasks as assigned. Responsibilities + Lead quality investigations related to in-the-market defects to identify root cause and implement corrective actions and preventative actions. + Collaborate with cross-functional teams to investigate failure modes and execute impact assessments to ensure appropriate countermeasures are developed and launched. + Interface with customers and suppliers to address non-conformances identified during manufacturing. + Lead process improvement initiatives utilizing Statistical Process Control (SPC) and Six Sigma methodology such as 5S, Value Stream Mapping, Control Plans, PFMEA, and Process Mapping. + Lead Manufacturing Quality Assurance aspects of process control, initiating projects to ensure that targeted process flows are effective and achieve operational requirements, and provide guidance to SMEs on root cause and corrective action (RCCA) activities. + Recommend process improvements to management and execute to ensure consistent implementation of internal requirements and external regulations and standards. + Provide status reporting regarding manufacturing process deliverables, dependencies, risks, and issues, communicating across teams and management. + Advise manufacturing and quality teams on the implementation of international standards and regulatory standards as they relate to the manufacturing of product and Good Documentation Practices (GDP). + Participate in the investigations and dispositions of product non-conformances and changes, CARs, and MRB. + Generate and maintain procedures, work instructions, and forms, as necessary to ensure standardization of practices. + Implement required changes to existing training programs and assist in training staff members. + Perform other tasks as assigned. Essential Skills + 5+ years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility. + 5+ years of experience with technical documentation for complex activities in the areas of the Quality System that includes corrective actions, change control, quality audits, and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment. + Strong understanding of global pharmaceutical and biotechnology product regulations. + Proficient problem-solving skills using continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent. + Demonstrated proficiency in multiple quality systems including exception management, change control, document control, product release, etc. with strong decision-making skills utilizing risk management. + Quality System Knowledge (e.g. ISO standards). + Advanced skills with MS Office software are preferred. + Able to lead change environment across multiple sites and customers globally. + Able to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors. Additional Skills & Qualifications + Certification desired in ASQ, Green Belt, Lean, or equivalent. Work Environment The Quality Engineer works closely with Operations, Manufacturing Engineering, R&D, and Quality teams across the organization to lead and drive quality through process improvement assessment and continuous improvement. The Quality Engineer will be the key point of contact for quality-related issues in process nonconformance, manufacturing workflows, and quality providing leadership in project management and technical areas for improvements and enhancements of process and testing requirements. The Quality Engineer will be the primary contact responsible for quality events related to in-the-market defects and their corresponding root cause analysis and CAPA (Corrective Action & Preventative Action). Pay and Benefits The pay range for this position is $95000.00 - $110000.00 About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.