Danaher Corporation Sr. Qualification Engineer in Lodi, California
Generate, prepare and issue complex reports for assigned projects.
Review, implement, or revise product, project, and program quality activities.
Support project core teams throughout the phase to ensure compliance to Cepheid and Danaher policies and procedures.
Establish and monitor use of risk assessment tools for project tracking and management
Assure project adherence to Design Controls to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.
Identify and drive countermeasures in instances when deviations to the project plan occur.
Work effectively with all team members, stakeholders and supervisor
Coach and develop extended Quality team members as necessary to assure common understanding of the product development process and project goals
Effectively communicate and maintain visual tools for project tracking and management
Effectively employ lean and quality tools and concepts to maximize efficiency and quality.
Works with team members to develop team goals and plans, resolve problems and achieve goals.
Develop, plan, and execute qualification and validation protocols for manufacturing equipment, automation systems, and processes.
Develop validation Master Plans, process flow diagrams, test cases, and SOP's
Knowledge and skills:
Proven track record in injection molding product development.
Fast learner, and able to quickly become adept at using the Danaher Business System tool set
Readily accepts responsibility and accountability for project success and key decisions
Strong background and experience in NPI Quality for medical devices.
Experience in the application of production and process controls including process validation, process control plans and statistical process control.
Experience developing business processes and quality systems enhancements in a mature industry that has stringent quality regulations.
Advanced experience with risk management and design control principles
Experience representing their department during quality system audits.
Self-starter with a demonstrated ability to focus efforts, overcome obstacles and complete key projects
Communication skills, both oral and written.
Ability to work effectively in a team environment and build strong working relationships.
Ability to constructively challenge concerns and engage in transparent conversations.
Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
Foster an environment that values diversity and inclusion.
Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills).
High degree of initiative and self-motivation.
Strong analytical and problem-solving skills.
Proficient with Microsoft Office (Word, Excel, PowerPoint).
Experience in product mechanical evaluation & testing and GD&T
Hands-on experience in advance statistical analysis such ANOVA, Cpk, PPk, DOE, Gauge R&R.
Experience in Regulated environment such IATF16949, ISO9001 or ISO 13485
Bachelor’s degree in Industrial Engineering field with 5+ years of related work experience in Manufacturing OR
Master’s degree in Industrial Engineering field with 3+ years of related work experience in Manufacturing OR
Doctoral degree in Engineering field with 0-2 years of related work experience in Manufacturing
Injection Plastic Molding process experience
Experience in Lean manufacturing and/or Six Sigma
Knowledge of CFR 21 Part 820 (QSR)
Master’s degree in Engineering field with 3+ years of related work experience OR
Doctoral degree in Engineering field with 0-2 years of related work experience
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid