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Director, Sterilization NJ Sites - Wayne, NJ in Wayne, NJ at Getinge

Date Posted: 12/16/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Wayne, NJ
  • Experience:
    Not Specified
  • Date Posted:
    12/16/2018

Job Description

Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Our Director is responsible for providing strategic leadership for the New Jersey sites by working with the Executive Management Team to establish long-range goals, strategies, plans and policies.  The primary responsibility of the position is to establish implement and maintain Sterilization, Biocompatibility, Environmental Monitoring and Laboratory Services Programs that are fully compliant to all applicable regulations world-wide.

Key Responsibilities:  

  • Generate, implement and maintain internal sterilization, biocompatibility, environmental monitoring and lab service procedures and systems that comply with applicable global regulatory requirements.
  • Ensure an effective Sterilization Program and maintain a sterilization revalidation schedule.
  • Evaluate site systems for sterile load release and assist in updating those processes to allow for the most efficient release of product to the market.
  • Write and/or review sterilization validation protocols and reports.
  • Establish biocompatibility procedures which ensure compliance to current standards.
  • Ensure effective global Bioburden and LAL Programs.
  • Ensure that Laboratory Services in New Jersey are effectively utilized and cost effective.
  • Support and facilitate external Quality System audits for these functions as needed.
  • Routinely report on the status of the Sterilization, Biocompatibility, Environmental Monitoring and Lab Service Programs to the Sr. Director Corp Sterilization, Biocompatibility and Environmental Monitoring.

Supervisory Responsibilities:



This role shall manage and be responsible for the overall direction, coordination and evaluation of the Quality System as it pertains to sterilization, biocompatibility, environmental monitoring and Lab services in the New Jersey sites. 



This position shall carry out supervisory responsibilities as needed in accordance with the organization’s policies and applicable laws. Responsibilities may include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Position Responsibilities: (Key responsibilities, authorities, and inter-relationships) 

  • Generate, implement and maintain internal sterilization, biocompatibility, environmental monitoring and lab service procedures and systems that comply with applicable global regulatory requirements.
  • Ensure an effective Sterilization Program and maintain a sterilization revalidation schedule.
  • Evaluate site systems for sterile load release and assist in updating those processes to allow for the most efficient release of product to the market.
  • Write and/or review sterilization validation protocols and reports.
  • Establish biocompatibility procedures which ensure compliance to current standards.
  • Ensure effective global Bioburden and LAL Programs.
  • Ensure that Laboratory Services in New Jersey are effectively utilized and cost effective.
  • Support and facilitate external Quality System audits for these functions as needed.
  • Routinely report on the status of the Sterilization, Biocompatibility, Environmental Monitoring and Lab Service Programs to the Sr. Director Corp Sterilization, Biocompatibility and Environmental Monitoring.

Supervisory Responsibilities:



This role shall manage and be responsible for the overall direction, coordination and evaluation of the Quality System as it pertains to sterilization, biocompatibility, environmental monitoring and Lab services in the New Jersey sites. This position is responsible for Sterilization, Biocompatibility, Environmental Monitoring and Laboratory Services at all three New Jersey sites.



 



This position shall carry out supervisory responsibilities as needed in accordance with the organization’s policies and applicable laws. Responsibilities may include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education Requirements:

A minimum of a Bachelor’s degree in engineering or physical sciences or equivalent is required.

Experience and Job Skill Requirements:

  • A minimum of 10 years of experience managing Sterilization Programs/Quality Assurance systems in the medical device industry. Minimum of 2 years managing teams across multiple sites.
  • A thorough understanding of the relevant industry standards as they apply to sterilization, biocompatibility, environmental monitoring and good laboratory practices.
  • Direct experience establishing environmental monitoring and sterilization validation programs is mandatory
  • Experience managing bioburden and LAL programs is mandatory.
  • 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.

We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired medtech company.