Customer Quality Manager - Recalls and Device Tracking

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 company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .”  LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

The Recalls and Device Tracking Manager leads the development, implementation and maintenance of Device Tracking and Recalls for LivaNova’s Neuromodulation business unit. This position oversees the timely and effective implementation of recalls (corrections and removals) around the world and the device tracking of neuromodulation devices. 

Responsibilities

• Establishes and maintains procedures and processes related to recall implementation and reporting and Device Tracking.

• Interactions with external industry or regulatory bodies including presentation of areas of responsibility as subject matter expert during inspections.

• Monitors department performance versus key performance indicators and reports on this performance to site and executive leadership.

• Leads, manages and develops direct reports by preparing objectives and metrics, communicating expectations, improving technical capabilities and measuring results against these goals. 

• Implements procedures to ensure compliance with ever-changing worldwide regulations.

• Leads effective meetings, conducts presentations, keeps quality records. 

• Maintains robust employee training programs related to device technology and customer-related processes.

• Defines and implements initiatives to enhance system efficiencies, productivity, and quality that are consistent with company changes and growth.  Supports and implements such changes without adversely impacting quality or regulatory compliance. 

• Develops and maintain effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints.

• Performs other duties as may be required by the manager.  

Education/Experience Required: 

• BS in Engineering or Science

• > 5 years of experience working in quality within the medical device industry.

• Proven track record playing a significant role in executing worldwide medical device recalls.

• Experience interacting directly with regulatory authorities, through in-person and/or written communications

• Proficient in MS Office including Word, Power Point, and Excel. 

• Strong interpersonal skills and excellent written and verbal communication skills. 

• Ability to prioritize and plan activities of self and direct reports.

• Resolves most issues with peers, but understands what issues are important to escalate to senior management. 

• Possesses in depth knowledge of applicable standards/regulations (e.g., EU MDR, AIMDD, ISO 13485, 21 CFR 806, 21 CFR 820, and 21 CFR 821) to ensure the documentation of functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements. 

• Familiarity with medical terminology.

Desired Skills and Qualifications

• MS in Engineering or Science

• Experience leading Medical Device Tracking per 21 CFR 821.

• Management experience

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $90 - $125,000 + discretionary annual bonus. Pay ranges may vary by location.

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates 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.