• Assists in the management of the following Quality Management Systems: Nonconformances, Deviations, and Returned Material Authorization (RMA).
• Responsible for acceptance activities: First Article Inspection Reports, Receiving, In-Process and Final Inspections as designated on the Device History Records (DHRs).
• Performs and documents Corrective and Preventive Actions (CAPA) investigations. Acts as lead on assigned CAPAs to develop and drive corrective and preventive actions and closure within prescribed timelines.
• Provides support to Operations as needed.
• Participates in the transition of new customer customer-designed into production.
• Assists with training.
• Supports FDA inspections, and customer and third-party audits as required.
• May be trained to perform internal quality audits.
• Follows established safety requirements and adheres to the Secant Group HSE Management System
• Integrates customer label designs into the Bartender software program and coordinates label printing with Document Control.
• Back up to Document Control Coordinator
• Performs statistical data analysis utilizing statistical software (Minitab and Excel).
• Develops and reviews equipment qualification and process validation protocols and reports.
• Performs and documents customer complaint investigations, root causand e analysis and develops corrective and e actions.
• Works with customers to provide required technical support and information regarding the investigation.
• Supports development and implementation of methods for sampling, inspection, testing, and evaluation of products.
• Reviews/approves records about the controlled production environment (cleanroom logs, monitoring reports)
• Completes Supplier Corrective Action Requests (SCARS) and communicates with suppliers regarding non-conformances, supplier changes, etc. Assists in maintenanthe ce of Approved Supplier List.
• Authors' documents, specifications, procedures, work instructions, validation protocol/reports, etc. as applicable.
• Follows established safety requirements and adheres to Health, Safety & Environmental Management System
• Performs other job-related responsibilities as assigned

• 3 years of experience in a related industry or regulated environment (e.g., ISO 13485, 21 CFR Part 820) in one of the following functions: Quality Control or Product Development.
• High School Diploma required. An associate degree related to life sciences or equivalent preferred.
• Hands-on experience with test equipment including the ability to understand the working mechanisms and methodologies
• Intermediate to advanced knowledge of MS Office Suite (e.g. Word, Excel)
• Self-starter with high attention to detail and the ability to work on multiple projects
• Strong written and verbal communication skills
• Knowledge of quality management standards, specifically ISO 13485 and ISO 9001.
• Knowledge of FDA Regulation 21 CFR Part 820.
• Able to read, analyze and interpret common scientific and technical journals, financial reports, and legal,l documents to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Strong problem-solving, and analytical skills, with a concentration on risk analysis (ISO 14971).
• Demonstrated project organizational skills required.
• Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables.
• Demonstrated ability to participate in and/or lead cross-functional teams, and ability to independently prioritize and execute projects and responsibilities.
• Excellent customer service focus and professionalism.
  

• Health Insurance: Medical with Rx plan / Dental / Vision
• 401k (retirement savings) with excellent company match
• Profit Sharing Plan
• Company Paid Short-Term and Long-Term Disability
• Year-End Incentive Plan
• Paid Time off
• Holiday Pay

Secant Group engineers biomaterials to facilitate the repair, recovery, and regeneration of the human body. Throughout the product lifecycle, we provide clients with consistent value, quality, and technical expertise. Our mission is to continually advance biomaterials technology into practical applications for the medical device and pharmaceutical industries.