Sr. Director, Process Validation and Statistical Techniques - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 9/5/2019

Job Snapshot

  • Employee Type:
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Job Functions: (Primary “essential” duties and responsibilities)

  • Generate, implement and maintain global PV and Statistical Techniques procedures and systems that comply with applicable global regulatory requirements. 
  • Delivering training to sites on PV and statistical techniques.
  • Evaluate site systems for PV and Statistical Techniques and assist in updating those processes to allow for the most efficient path to compliance.
  • Write and/or review sterilization validation protocols and reports.
  • Establish global PV and Statistical Techniques procedures which ensure worldwide compliance.
  • Support and facilitate external Quality System audits for these functions as needed.
  • Routinely report on the status of the PV and Statistical Techniques to the VP of QA and Compliance.
  • Support inputs to VP of QA and Compliance for departmental budget exercises in accordance with business strategy and production plans.

Required Knowledge, Skills and Abilities:

  • Minimum of 10 years of experience in Process Validation and Statistical Techniques in the medical device industry.
  • A thorough understanding of the relevant industry standards as they apply to Process Validation and Statistical Techniques and other related quality system elements.
  • Direct experience in applying/working within Process Validation programs is mandatory.
  • A thorough understanding of Statistical Techniques, both theoretically and functionally is required.
  • Experience working across multi-disciplinary levels, functions and regions is required.
  • Must be team oriented, with the ability to motivate and work well with diverse cross-functional teams.
  • Must possess strong analytical and process skills, and be computer proficient in EXCEL, MS Project, PowerPoint, Word, etc.
  • Must possess strong verbal and written communication skills.
  • Must be willing to travel (approximately 40%).

Minimum Requirements: 

  • A Bachelor’s degree in Engineering, Science or related field is preferred or equivalent experience. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
  • Minimum of 10 years of experience in Process Validation and Statistical Techniques in the medical device industry

Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.