Quality System Supervisor

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:

What You Will Love Doing

    —Management Representative responsible for maintaining the Quality Management System
    —Formulates and maintains quality assurance objectives
    —Writes, reviews, approves company GMP-related policies and SOP
    —Lead Auditor
    —Participates in 3rd party audits
    —Leads the CAPA, ECO and Nonconforming meetings and reviews
    —Designs and implements quality assurance training programs
    —Manages the Document Control and calibration process
    —Liaison to outside regulatory consultants
    —Performs quality assurance reviews of design documentation for compliance with stated requirements, including company quality records
    —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
    —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
    —Performs other assignments as required by the Management

Minimum Degree and Required Experience

    —B.S. (or higher) in Engineering, Science or equivalent education in quality related courses. ASQ Certification preferred
    —5 years minimum of progressively more responsible experience related to establishing and maintaining quality system elements as it relates to product development and manufacturing in the medical device industry
    —Working knowledge of standards for medical device development such as quality management systems, risk management, biocompatibility, and sterilization, including ISO 13485, ISO 14971, IEC 60601, ISO 10993, ISO 11135 and ISO 14644
    —Working knowledge of regulatory compliance processes involving regulatory bodies/standards such as FDA, Health Canada, and the European Medical Device Regulation
    —Reasoning Ability: Ability to define problems, interpret data, establish facts, and draw valid conclusions. Apply principles of logical or scientific thinking to a wide range of conceptual and practical problems
    —Technical skills: Ability to propose, coordinate, and direct activities to verify product compliance, performance, quality, and robustness
    —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 organization 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

What We Will Give You

    —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

To apply, send your resume and cover letter to jobs@blackrockmicro.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.

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