NATUS is looking for an enthusiastic and detail oriented Quality Assurance Engineer to join our Middleton, Wisconsin Team. Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.
The QA Engineer will Participate in the maintenance of quality system requirements, including: audits, CAPA, data analysis, design, production, and post production activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
- Establish and update quality system procedures in compliance with requirements for medical devices.
- Plan and conduct quality system audits in accordance with documented procedures and provide support on basic statistical methods, including sample size determination.
- Support external audits and regulatory inspections.
- Support Quality and Regulatory efforts with production site transfer and outsourcing efforts.
- Support product recall activities.
- Support initiatives focused on improvement of operational and business processes.
- Support Quality Assurance and Regulatory functions as necessary.
- Review and/or approve product specifications, test protocol/reports, and manufacturing/inspection processes.
- Work with New Product Development to effectively transfer new product designs into the manufacturing process.
- Assists with the creation of Design Transfer documentation.
- Assist in developing manufacturing processes and optimizing current processes to improve reliability.
- Provide input into process validation activities, including IQ, OQ and PQ requirements.
- Conduct Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implement corrective actions to eliminate quality problems.
- Use relational databases and reporting tools to collate and analyze quality data. Have knowledge of and use statistical data analysis tools (e.g. Minitab).
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Travel Required: Up to 15% travel may be necessary
Education and/or Experience:
- Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field, with a minimum of 1-4 years of experience in a Quality and/or Regulatory capacity.
- Current knowledge of international quality system requirements (e.g., FDA, QSR and ISO 13485 compliance)
- ASQ certified quality engineer (CQE), RAPS certification or Six Sigma Green Belt preferred
Skills and Abilities:
- Working knowledge of the Medical Device Directive and Canadian Medical Device Regulations (CMDR)
- Working knowledge on the implementation of ISO 14971
- Demonstrated proficiency utilizing quality tools (FMEA, Root Cause Analysis, process mapping)
- Skilled in statistical analysis of quality data
- Experience in software validation concepts, industry requirements and processes
- Strong collaboration, negotiation, and conflict resolution skills;
- Read, analyze and interpret general business periodicals, professional journals, legal documents and technical procedures.
- Effectively respond to common inquiries or complaints from groups of managers, customers, or regulatory agencies
- Effectively present information to top management Ability to write reports, business correspondence and procedures
- Work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry
- Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
- Ability to solve practical problems and deal with a variety of concrete variables, in situations where only limited standardization exists
- Interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to resolve complex systems problems and identify solutions to obstacles encountered while resolving problems
- Ability to calculate figures and amounts such as discounts, interest, commissions, percentages, area, circumference and volume.
- Ability to apply concepts of basic algebra and geometry
- Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.