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
- 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.
- 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.
- Quality engineer, quality manager, quality, ISO13845
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.