Quality Assurance Manager

• Implementation and improvement of Quality Processes that will ensure compliance with Regulations, Corporate and Local procedures, and specifications
• Interfaces with regulators during regulatory inspections/ audits
• Support change control activities for manufacturing operations
• Manage the release process, inspection, and batch release activities
• Oversee, initiate, investigate and approve non-conformance report activities as needed
• Develop and analyze statistical data and product specifications to determine present standards and establish proposed finished product’s quality and reliability expectancy
• Apply standard operating practices and problem-solving methodology across the organization
• Serve as role model and coach employees at all levels in the application of best practices
• Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements
• Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility
• Interacts frequently with all levels of internal management as well as across functions and franchises
• Manages overall coaching, training, development and succession plans for the team
• Identify and lead projects and initiatives to improve the quality system
• Interact with Baxter larger organization on projects and initiatives as assigned
• Financial responsibilities and accountability include department and capital budgeting and expenditure for areas of responsibility

• BS in science or engineering
• 5+ years’ experience in Quality, Manufacturing, Engineering, or related field which should include 2+ years of supervisory experience in Medical Device industry
• Thorough knowledge of applicable procedures, specifications, regulations, and standards
• Strong leadership skills and demonstrated success in managing mid-to-large teams
• Capable of managing in matrix and ability to interact successfully with multi-functions globally
• Strong analytical and problem-solving skills
• Ability to manage/supervise a team of employees
• Good communication and leadership skills
• Good interpersonal/communication/influencing/negotiation skills
• Good project management skills
• Good working knowledge of applicable quality and regulatory standards and regulations
• Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment
• Excellent command of process validation and risk management for medical devices
• Thorough knowledge of applicable procedures, specifications, regulations, and standards
• Demonstrated experience managing quality personnel, specifically Quality Engineers, managing performance and developing teams
• Prior supervisory/leadership experience
• Experience with mechanical and biological products, and/ or chemical processing
• Set statistically valid inspection requirements, including identifying test methods and sampling plans and assist with designing inspection fixtures
• Assure measurement systems are capable using MSA, when applicable
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

Previous Quality Auditing experience is desirable

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits
• Support for Parents
• Continuing Education/ Professional Development
• Paid Time Off
• 2 Days a Year to Volunteer