Document Control, CAPA, and QMS Engineer

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.  

The Cardiopulmonary Business unit has a unique portfolio of leading cardiopulmonary products that are used to treat millions of patients worldwide. Through a complete range of cardiopulmonary equipment and disposables led by the worlds #1 heart lung machine, LivaNova has been offering customer centric integrated perfusion solutions for decades. We are taking the next step in our commitment to innovation and development of perfusion practice with the launch of the completely redesigned Essenz Perfusion system. The Essenz Perfusion System is built on a 50-year legacy of trusted partnerships with perfusionists. It is designed to meet evolving standards of safety and reliability to deliver lifesaving care to patients.

Are you a proven Document Control Specialist that has worked within quality systems to provide support to many functions of a business? Are you looking for a role that will provide you with the opportunity and the space to bring vision and innovation to an evolving and growing business? If that sounds like you and you are curious to find out more about who we are and what we could offer you, please keep reading!

YOUR NEW ROLE

This is a role that will work under limited supervision, setting own priorities. Position is accountable for various operations within the quality assurance function. Controls area of responsibility to achieve end result that supports quality and effectiveness on the device when used to treat our patients.

Responsibilities:

• Administer the change request and document release process including use of EDMS System.
• Administer Records Retention of Quality System Records both on-site and at off-site facility.
• Maintain all changes to the Ship-to-Stock program/lists. (Site Specific)
• Manage related processing tasks and ensure the integrity of data entered into the ERP system.
• Participate in development of strategic plans for the department and recommends changes to achieve the goals that support overall business objectives.
• Resolve problems within area of responsibility, recommending changes to operating policy when necessary.
• Participate and promote subordinate participation on cross-functional teams. 
• Schedule and prioritize tasks to assure the best results for internal and external customers.
• Update departmental SOP’s and procedures to meet the needs of the Company.
• Perform related duties as required in support of the Training Coordinator
• Perform other related duties as required in support of company and departmental objectives.

Qualifications:

• Ability to work on-site 5 days/week.
• Bachelor’s degree in relevant field or equivalent experience in document control (work experience of 2 - 3 years in document control).
• Working knowledge of the Quality System, appropriate regulations and standards.
• Problem solving ability and analytical thinking necessary to perform required auditing function.
• Strong knowledge and ability to use the Microsoft Office Suite (Word, Excel, Power Point)
• Other software programs as required to perform duties

WHAT WE CAN OFFER YOU

In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

• A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
• Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians
• Exposure to high-tech industrial manufacturing processes, including mechanical fabrication and electronics assembly

Compensation & Benefits:

• A reasonable estimate of the salary for this position is $70-80k/yr. + discretionary annual bonus.  Pay ranges may vary by location
• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• Retirement & Savings Plan (401K)    
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules

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.