Plans, coordinates, and directs quality assurance and regulatory affairs programs designed to ensure quality production of multi-electrode arrays, data acquisition systems, and other technical interfaces consistent with established standards by performing the essential duties listed in this job description personally, or through subordinate supervisors/employees.
Responsible for activities such as regulatory compliance testing which lead to and maintain domestic and international regulatory compliance for medical devices.
Responsible for assessment of device changes for regulatory implications and regulatory submissions. (FDA & CE)
Minimum degree and required experience:
B.S. (or higher) in Electrical Engineering required, or other engineering discipline, or equivalent.
5-10 years minimum of progressively more responsible experience related to product. development/product evaluation as it relates to process/quality/regulatory compliance.
5 or more years demonstrated experience and expertise in achieving worldwide regulatory requitements relating to medical electrical equipment.
Specific Skills/competencies desired:
Working knowledge of regulatory compliance processes involving regulatory bodies/standards such as CSA, TUV SUD, FDA, European Medical Device Regulation, CFDA, S. Korea, Israel.
Reasoning ability: proficiency in identifying problems, interpreting data, establishing facts, and drawing valid conclusions. Apply principles of logical or scientific thinking to a wide range of conceptual and practical problems.
Working knowledge of standards for medical electrical equipment development such as biocompatibility, sterilization, risk management, and quality management systems including IEC 60601, ISO 10993, ISO 11135, ISO 14971, and ISO 13485.
Technical skills: Ability to propose, coordinate, and direct testes to verify product compliance, performance, quality, and robustness. Remain current on relevant standards to support product compliance testing for both new and existing products. Strong working knowledge of safety testing equipment and techniques for the purpose of safety and environmental compliance testing.
Strong interpersonal skills: Function as a “team player” and work constructively and cooperatively with all departments in the interests of the business. Effectively communicate with all organizational elements and motivate people in a positive, constructive manner.
Good organizational skills: must be able to manage multiple tasks and prioritize workflow while working independently.
Working knowledge of Microsoft Suite (Word, Excel, and PowerPoint) required. Strong Excel skills required including VLOOKUP, Pivot Tables, and statistical analysis.
Knowledge of FDA Quality Systems Regulations.
Experience in establishing and maintaining quality system elements.
Experience in auditing and CSA inspections.
ESSENTIAL JOB DUTIES
Manage and motivate QA/RA team in a positive, constructive manner.
Management Team meetings: input on company strategy and manage QA/RA budget.
Generate and review regulatory compliance test plans & results to support regulatory submissions. Function as a mentor for research and development engineers regarding techniques to achieve safety, quality, and product robustness.
Coordinate regulatory testing with external laboratories.
Analyze component and field product failures; recommend corrective actions to improve failure rates.
Remain current and knowledgeable of all compliance standards applicable to domestic/international agencies.
Review software and hardware design requirements and offer improvement and provide technical direction with respect to applicable standards.
Propose, design, and conduct tests to validate and verify product design features.
Perform statistical analysis of test results.
Generate design files for products.
Coordinate with other engineers and other functional areas, i.e., manufacturing to accomplish design integration, prototypes, etc.
Participate with innovation team and client groups/teams formed to examine and evaluate technologies, procedures, and processes and make recommendations.
Perform other assignments as required by management.
Co-ordinates the following QA functions:
Formulates and maintains quality assurance objectives
Official Correspondent for FDA facility registration and other matters
Management Representative backup.
Performs quality assurance reviews of design documentation for compliance with stated requirements, including company quality records.
Writes, reviews, approves company GMP-related policies and SOP.
Designs and implements quality assurance training programs.
Prepares quality metrics for management reviews.
In conjunction with Engineering, determines inspection characteristics for incoming, in-process and finished components and products.
Coordinates receiving inspection of components and contracted product.
Maintains a working knowledge of government and industry quality assurance codes and standards.
Additional Salary Information: Bonus
Internal Number: 002
About Blackrock Microsystems, LLC.
Founded in 2008 in Salt Lake City, Utah, Blackrock draws on a legacy of high-tech innovation that began with Bionic Technologies, a spin-off from the University of Utah in 1997. This company started by Brian Hatt and Professor Richard A. Normann, the inventor of the Utah Electrode Array, was later acquired by Cybernetics Neurotechnology Systems Inc. (CKI). Having made major strides in applying the technology to the human body, the research business of CKI was then purchased by Blackrock Microsystems, LLC.
Blackrock prides itself in promoting work/life balance and a positive work environment.