Synergy Bioscience is a startup company that provides medicinal product development support, laboratory testing, and quality compliance consulting services to our partners in the pharmaceutical and medical device industries.

Our mission is to support our clients with their product development and commercialization efforts by providing world-class services in a timely manner without compromising their business confidentiality.

We are looking for a Supplier Quality Management Specialist to help with reviewing a large number of different audit findings related to supplier quality. The ideal candidate should be able to:

• Analyzes audit reports findings and categorizes them in terms of criticality and determines trends and recommends corrective actions.
• Review the current SOPs, and regulatory requirements, determine if a compliance gas still exists, and determine how it should be addressed.
• Initiation and ownership of NC and CAPA, build proficiency in problem-solving and root-causing activities.
• Participate in the development and improvement of the supplier manufacturing processes for existing and new products.
• Develop an understanding of risk management practices and concepts and become proficient in process risk.
• Support the QMS with QE support. Interpret quality data and non-conformances.
• Perform failure evaluations, determine root cause, and implement corrective action.
• Work with Operations and Manufacturing Engineering on production process flow, PFMEA, and Master Validation Plan.
• Work closely with contract manufacturers on product transfers and process validations, help define in-line inspection points to improve product quality, and author product quality plans as needed.
• Own and manage individual CAPAs. Work with a cross-functional team to investigate root causes and drive corrective actions.
• Support risk management activities. Able to update risk management files and draft Health Hazard Evaluations as needed.
• Review and approve interdepartmental records, documents, and SOPs to ensure conformance with the regulations and guidelines.

Experience:

• 5+ years of experience in Supplier Quality Management for Medical Devices and Combination Products.
• 5 + years of experience in FDA and/or ISO 13485 audit remediations in regulated medical device settings, with hands-on knowledge of regulations with a minimum of three (3) years in quality is required. Experience in medical devices manufacturing; experience with software-driven electro-mechanical medical devices is highly preferred.
• Ability to read, analyze and interpret national and international regulations and quality standards.
• Ability to effectively communicate and present information to top management and auditors from various compliance agencies.
• Ability to communicate efficiently and effectively with all levels within Quality as well as cross-functionally with departments such as Manufacturing, Engineering, and Purchasing.
• Proficient in the areas of statistical principles and applications; qualitative and quantitative data analysis; DOE, Acceptance and Sampling; process improvement/optimization; gage R&R measuring systems; and system and product audit.
• Ability to work independently or under minimal supervision
• Understanding of manufacturing processes, challenges, and solutions
• Working knowledge of statistical programs (Minitab or other statistical packages)
• Knowledge of ISO standards for Class I, II, and III medical devices is preferable (ISO 13485, 14971)
• Working knowledge of electronic quality management systems and/or manufacturing execution (ERP) systems
• Exceptional analytical, electronics and electromechanical aptitude, problem-solving, and root-cause analysis skills
• Excellent organizational skills
• Strong written and verbal communication skills

Duration: 1 year or more

Location: Remote Work

Type: Consulting on 1099 or C2C.