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Software Quality Manager
Ref No.: 17-00095
Location: Concord, California
Position Type:Full Time/Contract
Start Date: 04/03/2017
** Must have medical device experience**
Key points: They have design assurance engineers who have mechanical, electrical, chemical but not software backgrounds.
They recently hired a few SQEs and need a team manager to lead, so experience with software projects is key.


PRINCIPAL DUTIES AND RESPONSIBILITIES:
  • Primarily responsible for leadership of software quality assurance activities for medical device software under FDA Quality System Regulation and ISO 13485 registered quality systems.
  • Working team lead/ small group manager, supervising the day-to-day activities of Software Quality Engineers assigned to new product development and sustaining engineering teams developing embedded medical device software and firmware
and standalone medical device software.
  • Works with internal (company) teams and out-sourced teams under a traditional waterfall or Agile development models.
  • Participates in code review of embedded C code. Familiar with C coding standards, integration and system verification testing, including automated testing systems.
  • Participates in medical device software risk management activities; familiar with risk management including ISO 14971.
  • Ensures appropriate pre-market software defect review and disposition.
  • Work with internal team on review and disposition of software defects affecting product in field.
  • Develop and implement with R&D metrics to measure effectiveness of software development process and software quality.
  • Conducts personnel reviews, mentoring, team development, Client forecasts.
  • Maintains and improves the software development process from a quality/ regulatory perspective to ensure compliance to FDA requirements, ISO 62304 standard and FMC Design Control process.
  • Works with R&D project and engineering managers to identify schedule and resource requirements for software development projects (cross-functional new product development team and sustaining).
  • Responsible for reviewing, approving and auditing software related deliverables to project requirements.
  • Builds collaborative relationships with stakeholders, key partners, and team members.
  • Serves as a role model in aligning own priorities/activities with those of others and with functional goals.
  • Anticipates and overcomes obstacles with a pragmatic approach to achieve goals and commitments.
  • Provides technical guidance and support throughout the product life cycle.
  • Contributes to creation, review and approval of software related project deliverables (plans, protocols, and reports).
  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
  • Interprets company-wide policies and procedures. Involved in the development, modification, and execution of company policies that affect immediate operations with potential company-wide effect. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
  • Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.
  • Technically proficient in the specific department and knowledge of industry practice and business principles.
  • Interacts frequently with internal departments and external customers/vendors; particularly in problem resolution.
  • Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary action, and terminations.
  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:
  • The physical demands and 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.
  • Up to 10% Travel

EDUCATION:
  • Bachelor's Degree required; Advanced Degree preferred
  • Advanced degree preferred, Six Sigma Green (or Black) belt is a plus.
EXPERIENCE AND REQUIRED SKILLS:
  • 8 – 12 years' related experience; or a Master's degree with 6 years' experience; or a PhD with 3 years' experience; or equivalent directly related work experience.