Quality Manager

  • location: Lake Geneva, WI
  • type: Permanent
  • salary: $75,000 - $85,000 per year
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job description

Quality Manager

job summary:
Medical device manufacturing company is currently in search for a strong Quality Manager that has experience with ISO13485. The ideal candidate will have previous experience within the medical device industry with a minimum of three years of manufacturing experience with project coordinator and medical device ISO 13485 environment.

 
location: Lake Geneva, Wisconsin
job type: Permanent
salary: $75,000 - 85,000 per year
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
  • Quality Manager is responsible and accountable for maintaining the ISO 13485:2016 Quality Manual, (SOPs) Procedures, Work Instructions, and Forms. (QMS Document Control)
  • Maintains documentation control per ISO-13485:2016 and FDA regulatory compliance.
  • Oversees, schedules, and hosts ISO 13485:2016, FDA audits.
  • Delivers training to select auditors and other personnel to ensure that audits and activities comply with the relevant ISO 13485:2016 requirements and FDA CFR 820 compliance.
  • Manage incoming materials, work-in-process, and final release (SOPs) and associated documentation.
  • Manage Sr Validation Engineer, executing IQ OQ PQ validations and other essential tasks within the Sr Validation Engineer's position.
  • Manages Quality supervision and inspection dept.
  • Performs root cause investigation of customer complaints and non-conformances and oversee implementation of corrective actions
  • Hosts customer supplier qualification audits, onsite and virtual.
  • Supplier Qualifications. performs outside supplier services related to Quality & Regulatory Dept.
  • Resolve day-to-day manufacturing quality related concerns.
 
qualifications:
  • Minimum Bachelor's Degree, or applicable accredited certifications pertaining to job responsibilities that are equivalent.
  • Minimum of three years of manufacturing experience with project coordinator and medical device ISO 13485 environment.
  • Demonstrated knowledge of project coordination per ISO13845:2016 regulatory requirements & CFR820 compliance.
  • Experience with SOPs, Validation, Protocols, capability, statistics.
  • Ability to effectively use statistics associated with ensuring product ISO 13485:2016
  • Highly detail oriented. Strong organizational and time management skills.
 
skills:
  • Quality engineer, quality manager, quality, ISO13845
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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