Quality & Regulatory Affairs Manager
Based in Salt Lake City, Utah
Blackrock aims to provide Best of Class approved neurosciences tools to the research community to push the boundaries of human applications. We are a high-tech company that continuously innovates to empower researchers to better understand the brain.
We also aim to be the provider of implantable neural interfaces to restore function to people with neurological disorders. Blackrock already delivers some of the most critical components of leading BCI set-ups. We spend every day building technology that will benefit patients suffering from paralysis disorders, neurological diseases (ALS, Alzheimer’s, Parkinson’s), and neural dysfunctions (epilepsy, brain trauma).
Join us in the challenge and contribute the following:
—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
—>Participates in 3rd party audits
—>Performs quality assurance reviews of validation documents (protocols, technical reports, etc.)
—>Investigates customer complaints regarding quality
—>Creates product labeling
—>Maintains a working knowledge of government and industry quality assurance codes and standards
What We Will Give You
—A schedule with some flexibility
—Access to a diverse, multicultural and caring family-like team
—The challenge of fitting various employee and company organized events (hiking, biking, football (soccer), volleyball, gaming…) into your working day
—A free bike/ski helmet
—Fantastic facilities with showers, bike parking and a direct view of trails up the Wasatch Front
—Medical, vision and dental insurance
—Life and AD&D insurance
—Short and long-term disability insurance
—Flexible vacation/sick leave
—Paid maternity, paternity and adoption leave
—401(k) with generous matching and immediate vesting
—An opportunity for personal development and a career that will impact other people’s lives in a fundamental way
—A company that ensured continued employment of all employees throughout COVID while diligently focusing on the safety and health of every team member.
To apply, send your resume and cover letter to email@example.com.
Blackrock Microsystems is an equal opportunity employer. All qualified applicants will received consideration for employment without regard to color, disability status, national origin, race, religion, sex, or age. However, applicants must be currently authorized to work in the United States on a full-time basis.