Open Position: Regulatory Affairs & Quality Assurance Manager

Summary

INRAD is a medical device developer, manufacturer and distributor seeking a Regulatory Affairs & Quality Assurance Manager. Reporting directly to the President, this position is responsible for all areas of Regulatory Affairs & Quality Assurance.

Job Responsibilities

• Act as Management Representative
• Ensure quality system requirements are effectively established and effectively maintained.
• Report on the performance of the quality system to management with executive responsibility for review.
• Assist with establishing quality policy and quality objectives.
• Assist with ensuring that the quality policy is understood, implemented, and maintained at all levels of the organization.
• Maintain and continually develop INRAD quality systems, processes, and infrastructure to ensure compliance, effectiveness and continual improvement. Provide training when needed.
• Establish and drive successful fulfillment of strategy and objectives for the Regulatory Affairs & Quality Assurance Department. Monitor and report on progress to these objectives.
• Managing the daily activities of Quality Assurance personnel and maintaining acceptable morale in the QA department.
• Providing training and/or job coaching to Quality Assurance Technicians.
• Lead representative for INRAD for all regulatory and third-party quality system audits (i. e. FDA, ISO, Supplier Quality, etc.).
• Conducting internal audits and audits of suppliers as needed.
• Determine regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
• Prepare and manage regulatory submissions to the FDA, the Notified Body, Health Canada, and other applicable regulatory authorities.
• Liaison activities with regulatory bodies, suppliers, external consultants, and other third parties on RA/QA matters.
• Oversight and review of design control, process and design verification and validation activities in collaboration with Engineering & Operations teams.
• Ownership and administration of regulatory and quality document control systems, including writing, reviewing and approving controlled documents.
• Initiating and investigating complaint, variance, corrective and preventive activities and taking appropriate actions as needed.
• Administration of various quality system activities including but not limited to:
  • Identifying and addressing additional training needs.
  • Management of the INRAD preventive maintenance system
  • Reviewing and approving Sterilization Load folders for release
  • Management of sterilization validation activities
  • Reviewing and approving device history record documentation
  • Review and approving suppliers; maintaining approved supplier documentation
  • Material Review Program
  • Calibration system and scheduling
  • Corrective Action and Preventive Action System (CAPA)
  • Medical device reporting and vigilance reporting system
  • Microbial, Particulate and General Documentation review and approval system
  • Label and Labeling review and approval functions
  • Various other GMP and ISO Compliance activities
• Additional projects as assigned by the President

Job Details

• This position is in-person, onsite in our Kentwood, MI office
• Occasional Travel – Less than 10%

Job Knowledge, Education and Experience Requirements

• Four (4) year college degree or higher
• Minimum five (5) years work experience in FDA regulated facility (or equivalent)
• Previous Management experience
• Demonstrated knowledge of US FDA regulations, the MDD/MDR, Canadian Medical Device Regulations, and various quality system standards/regulations/laws, including but not limited to 21 CFR 820, ISO 13485, etc.
• Demonstrated experience in developing, implementing, and managing process quality controls, design and development of training programs.
• Internal / External audit experience
• ISO regulated industry experience medical device related
• Additional RA/QA training preferred
• Additional management / leadership training preferred
• Clean room experience preferred

Skills and Competencies

• Demonstrate a high level of honesty and integrity
• Skilled at managing ambiguity, influencing without authority and achieving results
• Strong interpersonal skills
• Ability to influence and impact positive organizational change
• Self-motivated with the ability to prioritize tasks and work effectively with others
• Understand Good Manufacturing Processes (GMP’s)
• Ability to read, understand, and follow specifications
• Ability to follow verbal and written instructions
• Understanding tolerances and variations
• Understand Production methods, manufacturing techniques, statistical methods
• Ability to multi-task proficiently
• Demonstrate excellent judgment and analytical skills
• Proficient computer skills
• Data collecting and charting / reporting
• Performing multiple tasks with minimal / no supervision
• Strong communication skills (written and verbal)
• Strong attention to detail
• Ability to adapt to changing environment/priorities
• Ability to manage and lead others
• Proficient, organized Management skills
• Ability to read / understand reports and provide evaluation / feedback
• Ability to lead audits with minimal assistance
• Excellent customer service skills
• Proficient mathematical skills
• Able to read drawings
• Ability to use measuring devices/hand tools

Physical Requirements

• Good vision
• Good hand-eye coordination
• Able to lift 25 lbs
• Able to sit or stand for four (4) hours at a time
• Moderate twisting, bending, and lifting
• Able to travel on occasion
• Able to work with / assemble small components