Manager, Quality Compliance

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Manager, Quality Compliance

November 2021

Durham, NC

HemoSonics, LLC is seeking Quality Compliance Manager who will be responsible for the management and maintenance of all Quality System compliance elements including developing company best practices and standards, continuous improvement, and ensuring compliance with regulatory requirements.

Key Attributes of the Successful Candidate:

  • Knowledge of domestic and international Quality standards such as FDA QSR, IVDD or MDD, CMDCAS, SFDA, JPAL, ISO 13485:2016, ISO 14971:2019, or other applicable standards and regulations
  • Ability to drive results in partnership with other department representatives and foster teamwork both in Quality and cross-functionally.
  • Excellent attention to detail, well-organized and able to work both independently and within a team environment.
  • Ability to work well in a fast-paced production environment and meet tight deadlines.
  • Problem-solver who thrives in a collaborative environment.

Key Responsibilities:

  • Establish and maintain policies and procedures (SOP, WI, and Forms) to ensure compliance with all applicable internal, domestic and international Quality regulations.
  • Ensure proactive compliance to federal regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union In Vitro Medical Device Directives (IVDD) as well as all other applicable regulatory requirements.
  • Identify gaps in GMP compliance as well as impact of changing regulations or industry standards. Develop and execute strategies to close gaps in an efficient and compliant manner.
  • Trend, analyze, and report on Quality data through management reviews in order to improve products and processes. Develop recommendations based on data analysis.
  • Serve as a Quality representative on cross-functional project teams and provide input on Design Control activities. Work with project teams in establishing product requirements and completing tasks to meet project timelines.
  • Serve as the Company’s lead for Supplier Audits and supplier evaluations, with primary responsibility for annual supplier audit schedule and audit planning.
  • Manage the Internal Audit program by developing annual schedule, coordination of internal auditors and communication with applicable departments.
  • Host regulatory body or 3rd party audits as necessary, ensuring appropriate organization, execution, and responses to audits are performed.
  • Final review and approval of Change Control, CAPA, Nonconformance, Deviations, Reworks, Investigational Studies and Research Reports.
  • Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated.
  • Review and approve non-product software validation plans, protocols and reports, ensuring quality and completeness of validation packages.
  • Collaboratively work with different departments to provide direction on GMP guidance and educate personnel on Quality Compliance best practices.

Education and Experience Required:

  • Bachelor’s Degree in Engineering, Biological/Life Sciences, Chemistry or related field and 7+ years of experience in Quality Compliance, with 2+ years of experience with IVD manufacturing processes.
  • Experience applying Quality regulations and standards (21CFR 820, ISO13485:2016, and 14971:2019) and establishing Quality Systems.
  • Experience in an FDA-regulated environment experience is required.
  • Significant experience and understanding of Quality compliance processes within the medical device/in vitro diagnostics device industry with an analytical and organized approach.
  • Demonstrable experience with Quality metrics.
  • Demonstrated, successful Project Management experience.

The position is based at our facility in Durham, NC and will involve travel to supplier sites as needed. HemoSonics requires employees to be fully vaccinated against COVID-19 or meet the requirements for medical or religious exemption.

To apply, please email your cover letter, resume and salary requirements to:

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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