Job Scope and Quality Impact:
To ensure compliance with the Axonics Quality System, ISO standards, FDA and Health Canada requirements, and City, County, State, Fire Marshall and Federal safety regulations. Maintenance and improvement of policies and procedures focused on delivering product and services that are in compliance with company Quality Systems and regulatory requirements.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Quality Systems: Maintain and improve company quality systems in compliance with FDA, International Standards (ISO), Canadian, and other regulatory agencies. This function is responsible for supporting company quality compliance and to provide control of processes, materials, and product in compliance with the Axonics Quality System.
- Management: Responsible for departmental supervision, training, and ongoing support of staff. Required to effectively communicate project goals and establish staff responsibilities and project tasks. Provide technical guidance and training (mentorship) to less senior staff members to contribute to their ongoing development within the company.
- Product Development: Is a key member of the product development team representing the Quality function. Steer and support the design control aspects of product quality, program management, and quality planning from product design through manufacturing.
- Process Verification and Validation: Provide input regarding appropriate statistical methods, test methodologies, test facilities and equipment. Coordinate testing and manage resulting documentation. This can include process validation, equipment installation/operational qualification, test method validation, etc.
- Production: May develop and implement quality inspection procedures including sampling plans, for production level components, sub-assemblies and finished goods. May also be responsible for the development and implementation of inspection methodologies, fixtures, measurement systems and calibration of such.
- Auditing: Conduct internal and external (e.g. supplier) GMP and ISO compliance audits. Reports results and recommendations for changes as required. Confirms acceptable follow up action on audits.
- Documentation: Create, review, and approve controlled documents on an electronic document control system (e.g. Quality Manual, work instructions, quality specifications, engineering specifications, lot history and device master records, procedures and validation protocols and reports).
- Training: Coordinates and/or provides training to staff in GMP/ISO, Quality Systems, and Safety awareness. Provides ongoing development and maintenance of training materials and records.
- Compliance: Ensures compliance with company quality policies and practices by participating in product and material reviews, assist in "troubleshooting" problems related to the manufacture, test, validation and documentation. Responsible for MRB, corrective action, process control, complaints, document control, calibration & preventive maintenance programs and product/process/equipment validation activities.
- Regulatory: Facilitate compliance with management strategy and regulatory agencies.
- Product Release: Review and approve lot history records and sterile load records to ensure product compliance with specifications and regulatory requirements. Provide support, guidance, education and training to personnel, ensure inspections, tests, and sterilization is performed in accordance with procedures.
- After Sales Product Monitoring: Coordinate attention to customer complaints, corrective actions, Medical Device Reports (MDR'S) and product recalls. As required research and investigate product failures and the reasons for such.
- Logs & Recordkeeping: Ensure compliance of quality related logs and records, including but not limited to CAPA, NCMR, ASL/APSL, equip0ment CAL/PM, and Training.
- Safety: Develop, implement and maintain required safety programs for flammable, hazardous and bio-hazardous material handling, storage and disposal in compliance with City, County, State, Fire Marshall and Federal safety regulations.
Projects and Other Duties:
- Performs other duties as assigned.
- Extensive experience and knowledge of regulatory requirements such as GMP's, ISO, etc.
- Knowledge of and ability to effectively use analytical tools and methods including statistics, DOE, and the use of computer software packages related to testing, data collection, calibration, etc.
- Strong understanding of medical device manufacturing processes, receiving inspection, in-process and finished device inspections, non-conforming material resolution, CAPA, and record keeping.
- Strong understanding of internal and supplier auditing, process validation, metrology, and inspection equipment.
- Thorough knowledge of applicable City, County, State, Fire Marshall and Federal safety regulations.
- Excellent communication skills (both written and verbal) required.
- Ability to work independently or in team setting required.
- Must be able to travel extensively (approximately 10-20% of time).
- MS/BS in Engineering or scientific discipline, or equivalent experience.
- 7 years Quality role in Medical Device or related industry.
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):
- Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
- Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
- Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
- Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
- Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
- Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
- Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Equipment Use & Abilities Required:
- Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
- Computer Skills: Software proficiency in Microsoft Office Suite.
- Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:
The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.