Job Summary
- Company
- Elite Technical Group, Inc.
- Location
- West Chester, PA 19380
- Industries
- Biotechnology/Pharmaceuticals
- Staffing/Employment Agencies
- Medical Devices and Supplies
- Job Type
- Full Time
- Employee
- Years of Experience
- 5+ to 7 Years
- Education Level
- Bachelor's Degree
- Career Level
- Manager (Manager/Supervisor of Staff)
- Salary
- 90,000.00 - 100,000.00 USD /year
performance bonus potential up to $15,000
Sterility Assurance Manager
About the Job
The Elite Technical Group is a Southern California talent acquisition staffing, contingency search and consulting firm. We provide sourcing, recruiting, qualifying and placement services to companies looking for contract, contract-to-hire and direct hire professional and executive level talent in the engineering, IT, and scientific communities. We match brilliant candidates with great companies. We invite you to visit our website; www.elitetechnicalgroup.com
Our distinguished client is a leading multi billion dollar global medical device company. They develop, produce and market instruments, implants and biomaterials for the medical device industry. Our client is present in every continent of the world, and employ thousands worldwide.
OVERALL RESPONSIBILITIES:
· This position is responsible for the North American implementation and management of Sterility Assurance and Product Development support activities. This position ensures compliance to the applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001. Other applicable Sterilization ISO standards, AAMI standards/reports and other guidance documents as required.
· This position provides Sterility Assurance program oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout the client's US manufacturing and product development systems. This should be accomplished by working closely with the Product Development (PD), Manufacturing, Quality and Regulatory groups at each facility.
· This position works closely with the client's Europe on the harmonization of product cleanliness and sterilization acceptance requirements and application of harmonized processes.
POSITION DUTIES & RESPONSIBILITIES:
Departmental Support
· Establish and maintain procedures, tools and methodologies to cover all SA programs
· Maintain knowledge of FDA & ISO sterilization guidelines
· Conduct technical assessments of contract sterilizers
· Train SA personnel to ensure SA program requirements are met
· Train Consultants on sterilization basics and corresponding regulatory requirements
· Correspond with customers’ special requests regarding the client's sterilization program
· Approve applicable expenses for goods and services used by the sterility assurance group
Product Development Support - US
· Work with client's PD groups, Europe and vendors to ensure initial product concepts will fit into the clien'ts SA system
· Work with PD groups to ensure timely and complete sterilization adoptions and validations of all new or changed products
· Train PD personnel in basic sterilization and reprocessing cleaning and in sterilization procedures
· Review all vendor sterility assurance validation protocols and reports to ensure Global regulatory requirements are met
· Collaborate with corporate packaging and validation groups to ensure a comprehensive approach to bring new/changed products into production
· Provide guidance to PD groups and plant personnel as required ensuring clear, concise and defendable protocols and reports are generated
· Ensure sterility validations (dose audits, EO validations, bioburden monitoring…) for all product families are maintained
Compliance Responsibilities
· Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
· Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
· Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
· Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
· Five to seven years sterilization and microbiological experience in the medical device and/or pharmaceutical industry
· Three to five years supervisory and/or management experience
· Knowledgeable in applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001.
· Well versed in government regulations and industry guidelines for sterilization, environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices.
· This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level.
· Working knowledge of applicable software, particularly Microsoft Office applications.
· Excellent organizational skills.
· Excellent multi-tasking abilities.
EDUCATIONAL REQUIREMENTS:
· BS Degree in Microbiology or Biological Sciences
OTHER REQUIREMENTS:
· Travel approximately 15%
This is a direct full time career opportunity. Our client's benefits package includes; medical, dental, profit sharing, matching 401(k) and much more. A relocation package is available for qualified candidates. US Citizen or Permanent Resident status is required, the client is not offering sponsorship at this time.
Become a "fan" of Elite Technical Group on Facebook
Follow us on Twitter: http://twitter.com/EliteTechJobs
Our distinguished client is a leading multi billion dollar global medical device company. They develop, produce and market instruments, implants and biomaterials for the medical device industry. Our client is present in every continent of the world, and employ thousands worldwide.
OVERALL RESPONSIBILITIES:
· This position is responsible for the North American implementation and management of Sterility Assurance and Product Development support activities. This position ensures compliance to the applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001. Other applicable Sterilization ISO standards, AAMI standards/reports and other guidance documents as required.
· This position provides Sterility Assurance program oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout the client's US manufacturing and product development systems. This should be accomplished by working closely with the Product Development (PD), Manufacturing, Quality and Regulatory groups at each facility.
· This position works closely with the client's Europe on the harmonization of product cleanliness and sterilization acceptance requirements and application of harmonized processes.
POSITION DUTIES & RESPONSIBILITIES:
Departmental Support
· Establish and maintain procedures, tools and methodologies to cover all SA programs
· Maintain knowledge of FDA & ISO sterilization guidelines
· Conduct technical assessments of contract sterilizers
· Train SA personnel to ensure SA program requirements are met
· Train Consultants on sterilization basics and corresponding regulatory requirements
· Correspond with customers’ special requests regarding the client's sterilization program
· Approve applicable expenses for goods and services used by the sterility assurance group
Product Development Support - US
· Work with client's PD groups, Europe and vendors to ensure initial product concepts will fit into the clien'ts SA system
· Work with PD groups to ensure timely and complete sterilization adoptions and validations of all new or changed products
· Train PD personnel in basic sterilization and reprocessing cleaning and in sterilization procedures
· Review all vendor sterility assurance validation protocols and reports to ensure Global regulatory requirements are met
· Collaborate with corporate packaging and validation groups to ensure a comprehensive approach to bring new/changed products into production
· Provide guidance to PD groups and plant personnel as required ensuring clear, concise and defendable protocols and reports are generated
· Ensure sterility validations (dose audits, EO validations, bioburden monitoring…) for all product families are maintained
Compliance Responsibilities
· Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
· Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
· Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
· Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
· Five to seven years sterilization and microbiological experience in the medical device and/or pharmaceutical industry
· Three to five years supervisory and/or management experience
· Knowledgeable in applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001.
· Well versed in government regulations and industry guidelines for sterilization, environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices.
· This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level.
· Working knowledge of applicable software, particularly Microsoft Office applications.
· Excellent organizational skills.
· Excellent multi-tasking abilities.
EDUCATIONAL REQUIREMENTS:
· BS Degree in Microbiology or Biological Sciences
OTHER REQUIREMENTS:
· Travel approximately 15%
This is a direct full time career opportunity. Our client's benefits package includes; medical, dental, profit sharing, matching 401(k) and much more. A relocation package is available for qualified candidates. US Citizen or Permanent Resident status is required, the client is not offering sponsorship at this time.
Become a "fan" of Elite Technical Group on Facebook
Follow us on Twitter: http://twitter.com/EliteTechJobs
