Director of Quality

4 weeks ago

Valencia, United States Valencia Technologies Full time
Job DescriptionJob Description

Position/Title: Director of Quality

Department: Quality Assurance

Supervisor: Senior Director, Regulatory and Clinical Affairs

FLSA Status: Exempt


About the Company: Valencia Technologies is a neuromodulation company transforming the standard of care for urgency urinary incontinence with the development of our revolutionary eCoin technology. With recent FDA approval, Valencia Technologies is ramping up all aspects of business to deliver effective therapy and impact the lives of millions. Join our mission to become the market leader in overactive bladder care as we bring patients and physicians a better therapy now and beyond, put patients first, and be a place of respect, excellence, and honesty for our employees and clients.


Job Summary: This employee is responsible for ensuring that the Quality System meets the needs of the company, is compliant to established standards/regulations, and helps to continuously improve the efficiency and effectiveness of the quality system.

Responsibilities/Tasks: As Director of Quality, you will be responsible for:

  • Manage Quality Systems processes such as CAPA, Document Control, Internal Audit, and complaint handling.
  • Leading external audits.
  • Providing significant guidance and approval regarding development and manufacturing projects.
  • Serves as Quality Management Representative
  • Provides guidance and decisions on Operations and Design Control activities to ensure continued compliance with internal procedures, regulatory requirements, and standards.
  • Trains, recruits and maintains high quality staff
  • Leading the decision-making process for recall/field actions
  • Provide tactical and strategic direction on Quality-related matters
  • Ensuring the department has the leadership and resources to achive the company’s objectives
  • Interfacing to external entities on behalf of the Quality department

Duties include the exercise of discretion and independent judgment with respect to matters of significance.

Competencies:

  • Action Oriented: Displays high energy and enthusiasm on consistent basis, exhibits personal ambition and drive but not at expense of others.
  • Analysis of Data: Ability to analyze and challenge data prior to making decisions
  • Analytical/Critical Thinking: Able to breakdown raw information and undefined problems into specific, workable components that in-turn clearly identifies the issues at hand. Makes logical conclusions, anticipates obstacles, and considers different approaches to the decision-making process.
  • Attention to Detail: Sees and pays attention to details; recognizes the component parts of a procedure or object; verifies the correctness or error in an individual part or procedure
  • Initiative: Takes action, seeks new opportunities, strives to see projects to completion
  • Interpersonal Skills: Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
  • Persistence: Staying the course in times of difficulty; remaining motivated to accomplish goals in the face of adversity or obstacles
  • Problem Solving: Strives to understand contributing factors, works to resolve complex situations
  • Resilience: Bounces back from daily crisis, disappointments and frustrations
  • Teamwork: Accountable to team, works to meet established deliverables, appreciate view of team members, respectful

Qualifications:

  • Strong expertise of Quality Systems 21 CFR 820 and ISO 13485
  • Working knowledge of Word and Excel
  • Must have a BS in a science or engineering discipline
  • Must be able to work independently and collaborate with team members
  • Minimum of 8 years of related experience
  • Excellent written and presentation skills

Benefits:

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • 401K with Employer Matching
  • Paid Time Off
  • Paid Holidays
  • Professional Development Reimbursement
  • Annual Bonus Eligibility


Valencia Technologies is proud to be an equal opportunity workplace and is an affirmative action employer

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