Supply Base Process Engineer IV

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.
ndependently develops processes at suppliers. Identifies the requirements necessary at the supplier to start production and to ramp up to higher volumes. Works with suppliers to develop manual and automated processes and take them through validation.
Responsible for implementing and maintaining the effectiveness of the quality system.
1. Optimizes the manufacturing processes of suppliers to provide sustainable gains in cost effectiveness and quality improvement through capital projects, statistical analysis, design of experiments, and procedural changes.
2. Works with suppliers and new product teams to develop launch and ramp up process capabilities.
3. Start-up new products and equipment at suppliers: manages installation qualification, operation qualification, and process qualification. Ensures new products meet requirements.
4. Evaluates suppliers' processes in order to determine critical quality parameters and develops appropriate assembly and test plans at the supplier.
5. Ensures early supplier involvement in design reviews with engineering.
6. Develop and manage project and equipment schedules and corresponding budgets.
7. Works with Supply Base Managers to develop contingency plans with key suppliers.

Qualifications
Knowledge of regulations and standards affecting IVDs and Biologics.
Solid understanding of cGMP, FDA, and ISO standards, guidelines, and regulatory requirements
3-5 years experience in medical device manufacturing preferred
Strong process and equipment development experience desired
thorough understanding of installation, operation, and process qualifications
Self motivated individual with experience working in a team format
Ability to read, write, and understand English
Proven ability to manage multiple projects at once

Accountable for ensuring suppliers processes are robust and acceptable for product launch and for maintaining these processes throughout the production cycle.
Bachelor's degree



Abbott welcomes and encourages diversity in our workforce. EEO/AA

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