Manager, Quality Systems & Compliance (m/f/d)

Essential Duties & Responsibilities:

The Manager, Quality Systems & Compliance, will act as the Site Management Representative and will be responsible for leading MGI site-level Quality Control, Quality Assurance, and Quality Systems team function activities, Quality Management Systems (QMS), assure compliance to USA FDA, Health Canada, and other applicable regulations across IVD, RUO and ASR products, and all regulatory audit and inspection activities.

The scope of the role includes but is not limited to Initial Importer/Distributor, Software, Finished Goods, Raw Materials and Component release, Quality & Validation, Audits and other Site Compliance & Inspection Readiness activities. Maintenance of the Site Validation Plans, Quality Engineering with oversight for Root Cause Investigation, Product Disposition, Corrective & Preventative Action and Medical Device Reporting. The role is responsible for developing both short-term tactical objectives and execution plans in addition to long-term strategies to drive efficiencies through simplification of Quality processes and procedures while driving Continuous Improvement in distribution, manufacturing quality, product quality, and compliance performance.

• Provide the overall framework within which QA and QC operate, ensuring that there is a structure for managing quality across the company.
• Oversee quality assurance activities, ensuring that the development and manufacturing processes comply with relevant standards.
• Manage internal and external audit activities.
• Manage the quality control process, ensuring that all products meet internal and external specifications before release.
• Investigate and resolve quality issues through CAPA processes, ensuring timely and effective corrective actions.
• Lead, mentor, and manage the quality team by setting goals, ensuring accountability, and providing ongoing feedback, while fostering a culture of excellence and continuous improvement.
• Ensures MGI site’s compliance, inspection readiness, and project prioritization, aligning with regulatory requirements and business goals, while reporting to senior management.
• Drives implementation plan of controlled document management, reviews and approves various SOPs and documentation, including labels and labeling, master batch records, specifications, methods, and validation protocols, equipment qualification documents. (e.g., process, method, etc.), and change control management.
• Responsible for incoming material management, including receiving, inspection, storage, and distribution.
• Oversee the storage, distribution, and management of MGI’s IVD, ASR, RUO, and laboratory reagents and consumables, ensuring supplies are readily available for the labs when needed.
• Manage the organization and layout of the warehouse to maximize space utilization and ease of access yet maintained in compliance with FDA and ISO regulations and safety standards.
• Collaborate with Operations and Applications and Technical Success leaders to identify potential areas of process and product variability, address root causes, and implement improvements through the CAPA process to ensure the flow of quality products through the supply chain.
• Manage and direct effective maintenance and calibration programs, equipment safety programs, and equipment utilization.
• Utilizes data to assess the overall health and effectiveness of the Quality Operations processes / systems and identification of areas for process improvement.
• Serve as the Safety Officer, ensuring all safety protocols are adhered to and managing the company’s employee safety program.
• Act as the OSHA Liaison, ensuring compliance with OSHA regulations, managing safety audits, and responding to OSHA inspections.

Required Education & Experience:

• Bachelor of Science degree or higher in a relevant field such as Healthcare Business, Quality Management, Life Sciences, Engineering.
• A minimum of 8-10 years’ experience in the In Vitro Diagnostic Medical Device or Biotech Industry with experience in leading and developing quality teams.
• Broad-based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Working knowledge of FDA 21CFR Part 820 Quality System Regulation, ISO13485 standards. CLIA and CAP knowledge preferred.
• Demonstrate knowledge of the business impact of compliance issues and risk management.
• Lead Auditor certification.

Preferred Skills & Qualifications

• Experience managing quality teams.
• Experience in project management and continuous improvement methodologies (e.g. Six Sigma, Lean, Total Quality Management) preferred.
• Strong working relationships with Operations, Procurement, R&D, Regulatory Affairs, and the broader Global Quality & Compliance organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment.
• Ability to host / manage external Quality System inspections is required with preference for experience gained with hosting FDA and other health authority inspections.
• Highly collaborative and leads by example.
• Ability and willingness to roll up sleeves and engage to resolve day-to-day issues.
• Experience as a Safety Officer or familiarity with OSHA compliance is a plus.
• Flexibility required to manage urgent quality, compliance, or safety issues.