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.
The Staff Engineer, Quality Systems will manage and maintain the ISO90001:2015 Quality Management System established at Rapid Micro Biosystems (RMB) in order to support the demanding expectations of our Pharmaceutical customers. Oversee the activities required to meet quality standards. The incumbent must be a self-starter who is comfortable working in a dynamic, team-based environment to reach common objectives with aggressive schedules. This position will report to the Vice President of Quality.
Duties and Responsibilities:
Manage and maintain the company’s Quality Management System while maintaining ISO9001 certification, CE markings, RoHS compliance, and expected customer GMP compliance.
Maintain a strong customer centric environment while managing and leading cross-functional actions to support customer requirements and improvements.
Ensure product requirements are well documented and meeting customer and industry requirements at all times.
Maintain a strong proactive quality focus by anticipating problems, driving and providing input on solutions, leading and facilitating change to ensure effective improvements.
Work cross functionally to establish a strong culture around corrective actions and continuous quality improvements. Lead and facilitate the implementation of appropriate methods and tools, including advanced problem solving and statistical methods.
Lead, manage, and support product and process validations to ensure all requirements are met and the highest standards of quality are maintained.
Manage supplier selection, quality planning, metrics and improvement activities to achieve the highest levels of 1st pass yields.
Establish and execute the in-house calibration program. Maintain and improve the process and procedures. Evaluate the tools used to manage the program to ensure effective process
Lead, manage and administrate the CAPA program to ensure CAPAs are effective, timely, and completed in accordance with procedures and internal and external customer/stakeholder expectations
Develop, lead and maintain a comprehensive suite of metrics supporting the Quality System and products and maintain a rigorous schedule of reviews and planned improvements. • Establish and maintain metrics and reports to support Monthly Business Reviews and the Quality System Management Reviews.
Perform root cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
Coordinate and manage internal and external audits with certifying bodies and customers and resulting corrective actions and continuous improvement opportunities.
Ensure in-process inspections, metrics and statistics are in place to ensure product quality requirements are being met at all stages of the process.
Ensure final product documentation and records are accurately completed, approved and maintained; including non-conformances and deviations
Support R&D/New Product Development Projects as necessary
Act as back-up for Document Control and Training as necessary Skills:
Self-Starter. Ability to work independently as well as cross-functionally
Supports and drives process improvements and team culture
Ability to communicate and express ideas clearly, across all levels of the organization.
Effective verbal and written communication, analytical and interpersonal skills.
Must be able to understand the role in the overall business process and appropriately support all organizations
Ability to negotiate and influence with or without authority and manage expectations.
Ability to successfully work on multiple projects at once.
Essential skills to communicate and contribute outside of defined job description.
• Bachelor’s degree in Engineering or related field, or equivalent experience.
• 8-12 years’ experience managing Quality Systems in a manufacturing organization.
• 5+ years’ experience managing quality programs, helping to shape quality strategy.
• Strong ISO9001 experience required while Medical Device or Pharmaceutical experience highly preferred.
• Must have proven experience with problem solving methodologies. Experience with Six Sigma, Lean and Statistical Process Control preferred. Black or green belt certification desired.
• Previous experience establishing quality related policies and procedures.
• High volume consumables and strong process control knowledge highly preferred.
• Expertise in Microsoft Office applications including Project, Word, Excel and PowerPoint, Agile and MRP/ERP systems.
• Knowledge of software development/validation preferred
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.