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Quality Manager

Company: Miroculus
Location: San Francisco
Posted on: January 16, 2022

Job Description:

Miroculus is looking for a Quality Manager to actively participate in the development of a quality system to support product development, transfer and operations activities. In this role, you will have ownership over developing effective Quality processes and programs, reviewing specification and requirements for product and processes, managing certifications, monitoring products compliance, and overseeing all product development procedures to identify deviations from quality standards.Position Summary

  • Collaborate with leadership across the company to set quality benchmarks.
  • Develop, implement and communicate a clear strategic vision for quality to maximize employee alignment, engagement, and performance.
  • Work with teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
  • Develop an appropriate quality system and nurture its evolution to coincide with the growth and maturity of Miroculus and its products.
  • Develop and implement Miroculus' quality policies, programs, and methods to inspect, test, and validate product and production processes.
  • Monitor the quality and performance of incoming materials.
  • Engage with suppliers and contract manufacturers to ensure they meet the quality standards needed to produce Miroculus products and systems.
  • Monitor the quality, performance, and delivery of Miroculus products and systems delivered from Miroculus or its Contract Manufacturers.
  • Analyze production and operational processes to ensure adherence to internal guidelines and regulations.
  • Ensure high quality documentation based on the latest industry standards.
  • Implement QA/QC procedures and manage QC processes across the organization including incoming and outgoing inspections and QC in process.
  • Analyze quality data and issue corrective actions and process improvements.
  • Work with Project Engineering to ensure the reliability and maintainability of new and existing features.
  • Identify and drive continuous improvement of quality procedures.
  • Assist teams to develop/monitor KPIs/tools (eg MTBF Calculation, FMEA).
  • Assist operations to track and monitor the production flow throughout the manufacturing process from design phase to site installation to guarantee the highest quality product.
  • Ensure field complaints are analyzed, reported and corrective actions are prioritized and implemented.
  • Conduct internal and third party audits. Identify areas and opportunities to improve quality system processes.Qualifications
    • Hold one or more Quality Certifications (e.g CQE).
    • Highly effective communication, facilitation, coaching, and negotiation skills.
    • Adaptable to fast-paced, dynamic work environment with shifting demands.
    • Ability to identify, assess, resolve and where needed, escalate risks.
    • Demonstrated ability to accomplish goals while working across departments is required.Bonus Qualifications
      • Bachelor's degree in Engineering, Science, or other related field required (or equivalent combination of education and experience).
      • 5+ years' experience in quality assurance field, in a regulated environment;
      • Experience applying quality regulation standards (e.g 21CFR820, ISO 13485, ISO 14971, IVDD, ISPE Baseline guides and ASTM E2500-07 Verification Guideline).
      • Practical experience in design control risk management, validation, change control etc.
      • Experience with CAPA and failure investigation tools and techniques
      • Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis.BenefitsWe offer a rich package of benefits including:
        • Competitive medical, dental and vision insurance plans
        • FSA & HSA plans
        • 401(k) match
        • Subsidized commuter benefits and thrice weekly lunches for on-site employees
        • Flexible vacation policy and a generous suite of paid holidays including a week off at the end of the year
          About MiroculusMiroculus uses proprietary digital microfluidics technology to automate and miniaturize the most complex genomic protocols such as NGS library prep, synthetic biology, genome editing, and combinatorial chemistry in a compact, user-friendly system. Our vision is to make the most complex protocols easy and accessible to scientists everywhere. We are a tight-knit team who strives to work together according to our company values of humility, commitment, and solidarity.
          Commitment to DiversityMiroculus believes that diversity is a competitive advantage, that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender identity or expression, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, body size or shape, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
          Covid Vaccine RequirementFor the health and safety of our team members, vendors, and customers, Miroculus requires all employees to be fully vaccinated against COVID-19 and to show proof of vaccination. New hires will be given a grace period of eight (8) weeks to comply with this mandate. This requirement is a condition of employment with Miroculus, unless you would like to request an accommodation due to a disability or sincerely held religious belief.

Keywords: Miroculus, San Francisco , Quality Manager, Executive , San Francisco, California

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