Scanlan International, Inc. ยท 2 hours ago
Quality Assurance Manager
Twin Cities Area
Full-time
Onsite
Senior Level
$96K/yr - $154K/yr
5+ years expScanlan International, Inc. is a medical device company specializing in high-quality surgical instruments. They are seeking a Quality Manager to implement and maintain quality practices and ensure compliance with domestic and international standards, focusing on quality system improvement, supplier quality, and quality audits.
Health CareManufacturingMedical
Hiring Manager
Carmen Bamlett
Responsibilities
Maintain the effectiveness of the Quality Management System (40%)
Maintain state-of-the-art competency of relevant quality management system requirements and standards via training and certification records
Ensure measurement, analysis, and improvement processes are effective, meet quality goals and objectives, and reported to management at regular intervals
Collect and analyze information, identify and investigate existing and potential causes of product and quality system problems and take appropriate corrective and preventive actions
Coordinate quality system certification and auditing activities with the Notified Body and other regulatory agencies
Coordinate internal and supplier quality audit activities
Ensure production processes remain qualified and validated (30%)
Ensure packaging and sterilization processes are validated, with periodic revalidation as required for compliance
Verify that appropriate controls are in place for the routine production of sterile medical devices, such as cleaning, packaging, sterile processing, cleanroom monitoring, storing, and handling
Review and approve production process validations, re-validations, dose audits, lab test data/reports, etc. to ensure sterile medical devices remain safe
Manage quality control inspection, acceptance, and release activities (10%)
Define quality control sampling plans using sound statistical methods that ensure the confidence and reliability levels required by the risk analysis
Ensure inspection test, and measurement equipment/techniques are calibrated and capable of producing repeatable/reliable data to ensure conformance to specifications
Ensure inspection and test activities are planned to ensure requirements are met
Ensure segregation of nonconforming products to avoid mix-ups
Ensure quality records are verified and approved, indicating that devices manufactured meet quality requirements
Lead nonconforming material process (10%)
Ensure nonconforming materials are quarantined, identified, documented, and processed via MRB in a timely manner
Assist cross-functional teams in the investigation, review, and actions regarding nonconforming materials
Ensure effective communication with all parties impacted by the NCMR
Coordinate risk review and any required regulatory actions with regulatory affairs
Provide quality leadership to the Material Review Board (MRB) to ensure prompt and appropriate disposition of nonconforming products
Perform supplier quality trend analysis and reports
Manage document control and quality records and assist with tasks as needed by the manager (10%)
Ensure quality system documents meet business and regulatory requirements
Ensure required documentation is reviewed and approved before being released and previous versions are removed from use
Ensure quality records are secure and remain accessible for their retention period
Qualification
Required
Bachelor's degree in a technical discipline such as life sciences or engineering field or equivalent combination of education and experience
5+ years of quality management system experience working in the medical device field
3+ years of managerial or supervisory experience
Preferred
Master of Science - Regulatory Affairs and Quality Assurance
Professional ASQ Certification in quality
Sterilization, microbiology and biocompatibility experience
Statistical Process Control (SPC) and Lean Six Sigma training
Risk analysis process per ISO 14971
MS Word, MS PowerPoint, MS Excel, MS Outlook, MS SharePoint, Minitab, and electronic document management skills
Data analysis and writing technical reports using analytical software such as Minitab
Basic laboratory skills such as, safety, chemical storage, sample handling, weighing and balances
Benefits
Medical, Dental, and Vision Insurance
Group Life Insurance
Short-Term Disability Insurance
Long-Term Disability Insurance
401(k) Plan with Company Match
Workers' Compensation
Employee Assistance Program (EAP)
Regular Part-Time Benefit Eligibility
Training and Development Program
Tuition Assistance Program
Paid Time Off, including:
Holidays
Floating Holidays
Vacation
Earned Sick and Safe Time (ESST)
Company
Scanlan International, Inc.
Since 1921, Scanlan International has designed and manufactured superior surgical products to meet the ever changing technology of the medical industry.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Colette Lurken
Chief Financial Officer
Recent News
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