Returning Candidate?

Sr. Director, Quality Systems/Regulatory Compliance

All times are in Eastern Daylight Time.
Requisition ID 
4101
# Positions 
1
Location 
US-CA-Sunnyvale
Experience (Years) 
10
Posted Date 
6/20/2014
Category 
Operations - Quality
Position Type 
Full-Time Regular

Options:

Your application choices are:
Apply for this job online
Refer a friend to this job
Cepheid administers its personnel policies and conducts its employment practices in a manner that treats each employee and applicant for employment on the basis of merit and experience, without regard to race, creed, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), age, physical or mental disability, marital status, sexual orientation, citizenship status, ancestry, religion, gender identity, or any other protected characteristic as established by law.

Cepheid is an E-Verify employer. E-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Click on the attached links for more information:

E-Verify Poster (PDF) English                                        Right to Work Poster (PDF) English

E-Verify Poster (PDF) Spanish                                      Right to Work Poster (PDF) Spanish

More information about this job:

Job Summary:

The purpose of this position is to assume a leadership role within the company to manage and improve quality system and compliance processess by partnering with peers, customers and functional department leaders.

 

Responsibilities:

 

  • Oversee compliance processes (CAPA, Internal Audit, Field Actions, Customer Complaints) and implement improvements 
  • Promote the recognition of quality programs within the company to create a shared continuous improvement mindset across functional departments and reinforce basic continuous improvement principles. 
  • Develop and implement employee communication and training programs in connection with the company’s strategic goals, quality objectives, and operational systems.
Required Knowledge - Skills - and Abilities:
  • Bachelors Degree in a biology, chemistry, engineering or related field
  • Minimum 10 years experience in quality assurance, quality systems, and/or compliance role
  • Medical Device industy experience
  • Expert knowledge of US FDA and ISO requirements
  • Five years of Supervisory or Department Lead experience in managing both processes and resources
  • Strong computer skills
  • Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity
  • Extremely detail-oriented with strong organizational skills and high quality standards
  • Excellent written and verbal communication skills

 

Preferred Qualifications:
• Masters Degree
• Experience with a molecular diagnostic company
• Experience in a Class III medical device environment
• Experience in Operations, Manufacturing, and/or R&D
Physical Demands:
none