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LOTE Assessment Projects Associate

Invacare Corporation

LOTE Assessment Projects Associate

Simi Valley, CA
Full Time
Paid
  • Responsibilities

    SUMMARY:

    This position will oversee a diverse group of functional investigations that will be performed within the scope of the Quality department. 

    ESSENTIAL FUNCTIONS:

    • Conduct investigations into Medical Device Reports (MDR’s) with products with respect to applicable Federal regulations including 21 CFR 820, 803 and in accordance with ISO 13485 and internal Standard Operating Procedures

    • Assume lead role in investigating potential manufacturing / process issues with a goal of identifying potential root cause and assessing potential finished device impact

    • Investigation, monitoring, and follow up on CAPAs for completion and effectiveness

    • Author and approve investigation findings

    • Communicate with company personnel as to status of complaint investigation, recommended course of action, and the need for additional medical and/or supplementary information relevant to complaint investigations

    • Communicate with Quality departments as to the status of product analysis and the need for additional information relevant to the report

    • Able to participate in Risk Analysis activities including FMEA and PFMEA

    • Attention to detail and skill at auditing to ensure accuracy

    • Ability to work cross-functionally with various groups that have opportunity to impact the investigation outcome (Engineering, Operations, Quality, Commercial Operations, etc.)

    • Work closely with Quality Audit to assess current procedures/work instructions related to Quality and address deviations/findings

    • Monitor complaints received and provide trending and metrics as determined necessary for inclusion in management review

    • Review as needed Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release

    • Complete all required training applicable to assigned position

    • Additional duties as requested or required

    Required Skills Required Experience

    QUALIFICATIONS:

    • Bachelors in Engineering or science related field; Masters preferred

    • Experience working with heavy equipment and machinery

    • Five (5) years of process engineering, quality engineering, or investigatory experience in the medical device or FDA regulated field

    • Six Sigma Belt certification preferred

    • Life science field quality certification (CQE) preferred

    • Prior experience with root cause investigation tools and complaint file documentation

    • Knowledge of FDA (21CFR 803/806/820) and ISO (ISO:13485) regulations

    • Organized and details oriented; proven ability to meet deadlines

    • Strong analytical skills; verbal, and written communication skills

    • Ability to work individually and as part of teams

    • PC KNOWLEDGE TO INCLUDE MS WORD, EXCEL, POWERPOINT, ACCESS & VISIO, AND DATABASE MANAGEMENT

     

    An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet

  • Qualifications
    • Associates’ degree in Computer Information Systems or equivalent combination of training, education and experience.
    • Knowledge of Windows operating systems, standards, protocols and network environments.
    • CCNA certification preferred.
  • Industry
    Manufacturing