Quality Systems Specialist II

Jobangebot - BIOTRONIK SE & Co. KG

Connecticum Job-Nr. 1444700 / 46085
  • Arbeitgeber: BIOTRONIK SE & Co. KG
    Beschäftigungsart: Professionals Job
    Jobdatum: 12. Oktober 2021
    Fachbereiche: Ingenieurwissenschaften: Medizintechnik, Pharmatechnik
    Einsatzort: Lake Oswego, Oregon, USA; Nord-Amerika

    Quality Systems Specialist II - Jobangebot


    Quality Systems Specialist II

    As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

    BIOTRONIK is looking to add a Quality Systems Specialist II to our Regulatory Affairs Team. The Quality Systems Specialist II will support activities associated with compliance to FDA’s quality system regulations and HIPAA requirements as well as other associated legal and business concerns.

    Your Responsibilities

    • Conduct internal audits and drive resulting corrective actions.
    • Perform root cause investigations
    • Lead and ensure the completion of Corrective and Preventative Actions (CAPAs).
    • Participate in and lead process improvement projects across various departments
    • Coordinate day-to-day Quality System related activities including but not limited to directing and answering Quality System related questions based on current policies and procedures.
    • In cooperation with other departments; plan, develop and write Standard Operating Procedures (SOPs).
    • Interact with BIOTRONIK personnel to implement SOPs.
    • Active participation in Quality System management reviews
    • Review and approve procedural documents to ensure adherence to company and regulatory/industry standards.
    • Assist with training, education and communication campaigns designed to support BIOTRONIK’s Quality System.
    • Participate in FDA facility inspections at BIOTRONIK and support other BIOTRONIK subsidiaries’ activities related to inspections, as required.
    • Conduct potential HIPAA incident investigations
    • Process document change requests when needed
    • Other duties as assigned.

    Your Profile

    • Bachelor’s Degree required
    • At least two years medical device and/or pharmaceuticals quality systems experience
    • Working knowledge of medical device regulations such as 21 CFR 820
    • Experience conducting Quality System audits; ASQ Certified Quality Auditor certification desirable
    • Experience conducting root cause investigations and implementing corrective/preventive actions
    • Knowledge of HIPAA/HITECH requirements a plus.
    • Strong analytical skills. Reliable and timely decision maker (decisions based on relevant information, alternatives, risk)
    • Ability to work independently and as a team leader when needed.
    • Ability to apply project management and change management techniques to internal projects
    • Positive attitude and willingness to work as part of a team
    • Ability to work independently and as a team leader when needed
    • Technical writing experience desirable
    • Excellent communication skills and the ability to work with all levels of the Company
    • Strong organizational skills and attention to detail

    Occasional travel may be required.

    Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

    Location: Lake Oswego, OR | Working hours: Full-time | Type of contract: Undefined

    Apply now under: www.biotronik.com/careers

    Job ID: 46085 | Contact: Amanda Willott

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

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Quality Systems Specialist II

Jobkennzeichen Connecticum Job-Nr. 1444700 / 46085
Arbeitgeber-Profil: BIOTRONIK

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