Senior Engineer, Quality

Company: Rapid Micro Biosystems
Location: Framingham
Posted on: June 16, 2022

Job Description:

Winning the race to bring new healthcare products safely to--market--drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky's the limit. Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation.--Advancement--at RMB--affords an--opportunity to achieve--your personal goals and--develop your--passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and--can--make a--profound impact--on our business. Senior Quality Engineer The Senior Quality Engineer is responsible for oversight, inspection and testing of product quality throughout the manufacturing process. --Provide quality engineering support to manufacturing and suppliers with support when process changes are required. --The Senior Quality Engineer shall provide support to developing and implementing systems to ensure products or services are produced to meet or exceed customer requirements and expectations. Provide support and oversight to assigned elements of the companies Quality Management System. Primary Activities Responsible for performing the in-process and final inspection/test on products being manufactured to ensure design and performance requirements are met. Document nonconformance and deviations as conditions are found and ensure root cause and corrective actions are defined leading to a final disposition and closure of the nonconformance. Participate in the MRB process and the dispositioning of nonconforming product and components. Provide Quality Engineering expertise to maintain and improve product quality by investigating customer complaints and analyzing nonconforming material reports. Prepare the final product documentation packages and submit for review and approval. Organize and maintain the archiving of quality records. Support the continuous improvement of quality processes by revising procedures and submitting them into the ECO process. Provide support to Operations, Service and Engineering to drive improvement actions to meet targeted goals and objectives. Participate in the supplier and internal audits as assigned and provide support to any resulting corrective actions to ensure successful closure. Provide input to and maintain supporting quality metrics (e.g., field, manufacturing, and inspection) and key process indicators to identify opportunities for improvement. Skills Skilled in inspection and testing of complex capital equipment Skilled in quality system process development, improvement, and auditing Skilled in failure analysis and root cause determination, CAPA, 8D, DMAIC, A3, 5-why, fishbone, etc. Good verbal (including presentation) and written communication skills, especially technical report writing Ability to effectively lead and/or work on project teams Knowledge Working knowledge of ISO 9001 and/or ISO 13485 standards Working knowledge of CE and RoHS compliance Extensive knowledge of complex capital equipment and associated processes and testing methodologies Skilled in statistical methods and design of experiments using Minitab Knowledge and experience in APQP, PPAP (Applicable Part/Process Qualification Methodology). Lean manufacturing principles and methods, including A3, poke-yoke, value stream mapping, etc. Qualifications/Experience Technical degree, bachelors preferred, in electro-mechanical or electrical disciplines 3-5 years in a Quality or Test engineering role with complex capital equipment Ability to work in a fast paced, changing environment with minimal supervision. Work independently, establish priorities and make decisions. Needs to be ambitious and have a sense of urgency ABOUT RAPID MICRO BIOSYSTEMS: Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company's Growth Direct----the first and only growth-based system to automate rapid compendial QC Micro testing-ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation. Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes. Rapid Micro Biosystems is headquartered in Lexington, Massachusetts.-- Our--research & development,--and manufacturing--operations are located in Lowell, Massachusetts. Additionally, we maintain field--offices in Freising, Germany; Switzerland, and Singapore. Equal Opportunity: Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law. Please no phone calls or agencies, please.

Keywords: Rapid Micro Biosystems, Framingham , Senior Engineer, Quality, Engineering , Framingham, Massachusetts