Sr Engineer, Quality

Baxter International Inc. • Hayward, CA

2d • $96,000 - $132,000

About The Position

The Senior Quality Engineer provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation. This role may lead project-based individual contributors / contractors or mentor newer Quality Engineers as needed.

Requirements

• Strong technical writing, investigation and communication skills required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.)
• Minimum 3 years of experience in regulated manufacturing environment
• BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience.
• 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.

Nice To Haves

• Experience leading cross-functional teams preferred
• Familiarity with MINITAB preferred

Responsibilities

• Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods.
• Requirements for new/improved machines/processes/computer systems, including system requirements/ design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer.
• Supports the manufacturing plant through implementation of process improvements.
• Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements.
• Manage small projects (both new and improvement) to include cost, change management, implementation, and validation.
• Leads cross-functional teams.
• Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration.
• Perform statistical analysis to support Quality and Production.
• Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composes protocols, final reports, studies, experiments and general information reports for use by management.
• Routes documents in the Document Management System.
• Leads/coordinates validation efforts of new equipment and changes to existing equipment.
• Assist in evaluation of customer complaints, risk management and technical summaries.
• Assist in evaluation of supplier product/process changes.
• Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 210-211,820), Corporate Quality Manual (CQM), ISO 13485-2003, and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
• Supports, review and approve, and may own execution of CAPA investigation with use of DMAIC process and technical writing skills.
• Responsible for: Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
• Identifying problems relating to the product, process and quality system.
• Initiating and implementing solutions through designated channels.
• Establishing controls on a process and establishment of the verification/monitoring of such.
• Driving improvements into the production process, from conception to sustainable production methods.
• Maintaining a safe work environment for self and others at all times.

Benefits

• 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
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior