Quality Assurance Leader
2 weeks ago
The salary range for this role is between $110,000 and $120,000 annually. Compensation is determined based on the unique qualifications and experiences of each candidate, including their skills and educational background. As such, job titles and salary ranges may differ.
Title: Quality Manager
Location: North Barrington, IL (Onsite position)
Relocation assistance may be provided
Role Summary:
The Quality Manager is responsible for leading the mechanical testing team within the testing department, ensuring that the lab meets its objectives for quality, quantity, and timely delivery of test services. This role includes managing profit and loss as well as the lab's revenue generation. Engaging with customers is a crucial aspect of this position. Responsibilities include overseeing the quality lab to ensure compliance with quality systems and the execution of component and product testing services.
Essential Qualifications:
- Bachelor's or Master's degree in a technical, life sciences, or engineering field
- Familiarity with ISO 13485, ISO 17025, and FDA 21 CFR Part 820 cGMP standards
- Experience in quality assessment or auditing is advantageous
- 3-5 years of experience in Quality Engineering within the medical device sector is preferred
- Knowledge of Quality Systems Regulations, including ISO 13485, ISO 17025, and FDA 21 CFR Part 820 cGMP
- Experience in a supervisory role
Skills and Competencies:
- Strong organizational and coordination abilities, with the capacity to prioritize tasks and inspire team members
- High energy, meticulous attention to detail, and a sense of urgency
- Proficiency in Microsoft Office Suite
- Excellent analytical and problem-solving capabilities
- Familiarity with ASTM and ISO standard testing practices is preferred
- Strong customer focus with exceptional written and verbal communication skills
- Ability to multitask and work hands-on
Key Responsibilities:
- Oversee personnel and testing operations within the quality lab
- Engage in the quoting process for test services offered by the quality lab
- Ensure that the quality lab's resources align with the objectives of accepted testing
- Recruit and select direct reports with the necessary skills and competencies
- Review testing protocols to ensure appropriateness of methods and sampling plans
- Approve test reports for components/products, confirming adherence to protocol objectives
- Ensure timely completion of testing per approved protocols
- Collaborate with the Equipment Coordinator to support calibration and maintenance of lab equipment
- Provide supervision, performance evaluations, and mentorship for all direct reports
- Manage employee performance, including disciplinary actions in collaboration with HR
- Address customer complaints and conduct failure analysis related to quality lab activities
- Represent the organization during external audits by regulatory bodies and clients
- Maintain a quality metrics reporting system, ensuring data is monitored and reported to management
Benefits Offered:
- Competitive salary
- Medical Insurance (BCBS): Eligible from the first day of employment
- HSA-eligible health insurance
- Dental Insurance
- Company-paid Vision, Life, and Long and Short-Term Disability insurance
- TeleDoc program
- Identity protection services
- 401k safe harbor retirement plan
- 18 days of paid time off
- Tuition reimbursement program
- Paid time off for community service and volunteering
About Medical Murray:
Established in 1996, Medical Murray is a privately held company specializing in the production of finished medical devices, components, and subassemblies for clients globally, ranging from startups to major OEMs. Our expertise lies in the development, testing, and manufacturing of permanent implants, delivery systems, and complex catheters for various interventional markets. Our core values include Integrity First, People Matter, First Class Service, Inspired Innovation, and Community Service. For more information, please visit our website.
Medical Murray is an equal opportunity employer.
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