Open Position: Regulatory Affairs & Quality Assurance Manager
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.
- 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
- 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
- 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
To place an order, send your purchase order to:
- Toll-Free: 800.558.4647
- Email: firstname.lastname@example.org
- Fax: 616.301.7799