QA Specialist II
- Req No.
- Job Locations
- Quality Assurance / Regulatory
More information about this job
Would you like to join an innovative team creating technology to power groundbreaking insights in academic, clinical, pharma and biotech research?
It is an extraordinary time for Fluidigm. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.
At Fluidigm we are also building a positive culture where our people can do the best work of their careers, informed and influenced by our core values:
- Create what customers need next.
- Drive to make a difference.
- Collaborate and learn.
- Step up.
Fluidigm is looking for QA Specialist who will be responsible for various duties to establish a continuous improvement with vendors, engineers and the production team to build high quality reagent and instrumentation products. Address quality issues with the goal to eliminate errors at the root cause and maximize efficiency.
- Review and approve production QC records, including Manufacturing Batch Record (MBR), inspection records, and test reports.
- Ensure products meeting all specifications, and processes are followed.
- Manage, control and oversee manufacturing Nonconformance (NC), including Material Review Board (MRB) management and NC closure related activities.
- Manage, communicate and monitor Supplier Corrective Action Request (SCAR).
- Coordinate and support First Article Inspections (FAI) and Incoming inspection and measurement of critical key components to manufacturing
- Work closely with the Supply Chain, Manufacturing, and Engineering to resolve nonconforming parts and to eliminate the root cause of these errors.
- Hold responsibility for supplier’s, manufacturing in-process and final test Device History Records (DHR).
- Issue and control production and product deviation orders.
- Support and perform manufacturing related trainings for procedure and work instructions.
- Work on customer complaints with corrective and preventive actions.
- Overall responsibility for supplier quality management including selection, qualification, performance evaluations, supplier’s audits, quality agreements daily quality related communication.
- Executes equipment and software qualification/ validation protocols and accurately document results of the defined testing; then comparing and reporting those results to predefined/approved acceptance criteria.
- Organizes and presents qualification data, results, documentation, and reports within the appropriate equipment/system validation files and system manuals.
- Bachelor’s Degree in Science, Engineering, or related discipline
- American Society for Quality (ASQ) certification- CQE / CMQ-OE / CQA preferred.
- ISO 9001 or 13485 auditor certificate preferred
- 5 or more years of experience in medical device/ reagent manufacturing. Experience in pharmaceutical / in-vitro is a bonus.
- Strong understanding of ISO 13485:2016 and cGMPs. Experience in FDA, and other local, state and federal regulatory requirements associated with medical device and in vitro diagnostics manufacturing facilities and associated equipment is a bonus.
- Proven ability to implement process improvements, and to lead equipment validation/ calibration
- Good working knowledge of production processes, SOPs, drawings, and specifications.
- Ability to read, analyze, and interpret common scientific and technical reports, technical procedures, validation protocols and reports, operating instructions, general business periodicals, or governmental regulations.
- Ability to write reports, business correspondence, and procedures. Must be able to prepare clear and informative engineering and technical reports with accuracy.
- Ability to analyze data using mathematical concepts such as probability and statistical inference.
- Ability to define problems, collects data, establish facts, and draw valid conclusions.
- Ability to effectively present information to upper management and other groups.
- Strong knowledge of Microsoft Office365
- Highly motivated, self-disciplined individual with strong analytical skill
- Strong communication and organizational skills, and ability to work across the organization with all levels of employees
- Proven ability to multitask, set and manage priorities based on organization requirements
Ready to join an industry leader with a bold and ambitious mission that is enabling advancements in human health? Apply online with your resume!
The Company is committed to providing an inclusive and barrier free recruitment process to applicants with accessibility needs in accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act (AODA). If you require an accommodation during this process, please inform The Company of your requirements. We are an equal opportunity employer.