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
• 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

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• 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