Sterilization Plant Operations Manager

Join us today and make a difference in people's lives!

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.

Job summary:

This individual will participate in Arvada's critical sterilization project and will be responsible for supervision (once implemented) of the routine operations of ethylene oxide sterilization unit, including maintaining all compliance standards, record keeping, and documentation.

Responsibilities:

• Manages the sterilizer operation, load and unload the chamber, monitor the process, and maintain documents.
• Performs supervisory assignments for the department such as interviewing, hiring, performance appraisal, training, employee discipline, termination, and work review/scheduling.
• Prepares process documentation and statistical analysis of data, as required.
• Ensures maintenance and preventative program for the sterilizer chamber and associated equipment is performed per requirements.
• Releases sterilized loads.
• Assists with sterilization validation activities.
• Identify opportunities for product cost improvement, design or revised process to address customers' requests and manufacturing requests at the same time
• Processing and analysis of all reports relating to Sterilization.
• Increase knowledge across the Operations and Quality team on Sterilization topics.
• Archive all hardcopies of documentation
• Working with Quality for customer complaints, root cause analysis and initiate corrective actions.
• Liaise with quality to lead and assist in sterilization validation processes
• Participate in internal and external compliance audits.
• Familiarize and maintain knowledge of all Regulatory requirements, technical files, Intended Use Sterilization Parameters etc.
• Complies to all company policies and procedures, including health and safely compliance.
• Complete any other tasks assigned to you by your manager.
• Utilize internal tools and software's such as: Process Control software and Hardware, desktop and/or laptop computers, printers, EXACT database program, Mastercontrol, Workday, Microsoft Suite Products

Experience:

• Minimum 7 years' Production experience in medical devices or Pharmaceutical Manufacturing facility
• Experience working within a quality management system
• Experience working with automated Process Control systems
• Experience with Hazardous Substances, Dangerous Goods and Victorian OH&S regulations
• Ability to apply analytical skills and scientific technical principles in problem solving and development
• Strong interpersonal and organizational skills and the ability to work effectively as a team member
• Knowledge and experience in facility maintenance
• Energetic, proactive, and efficient

Education:

• Bachelor of Science degree in Biology, Microbiology, Biomedical Engineering or closely-related life science is required.

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.