PURPOSE OF JOB Responsible for providing experienced quality assurance support to general production process, initiatives, and projects considering product transfers and validations.
Support new product introductions to ensure the robustness of product builds.
Responsible for multiple highly complex major projects requiring innovative original solutions where results are key to successful completion of projects.
Work mostly independently with minimal supervision and work is reviewed at project milestones and/or on completion by Senior Management.
RESPONSIBILITIES Lead and/or support process, product and/or equipment validation transfers, and design process activities (e.g., IQ, OQ, PQ, etc.).
Execute equipment and process validation activities as required.
Review and ensure validation protocols as well as monitor quality policies regarding the transfer and validation processes of processes/products. Review process changes, resolve product quality issues, and support implementation or transfers of new products by reviewing quality, testing plans, and quality transfer strategies. Travel and carry out evaluations of new products at the level of product quality risks as well as the transfer and validation strategy.
Ensure company/manufacturing process comply with federal, state, local, and industry standards and regulations.
Lead and maintain clear and effective communication with the local and corporate Quality departments to ensure alignment of criteria and the success of the projects in a timely manner.
Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, and requirements of the projects.
Timely escalation of any issue that threatens project continuity Ensures that products meet the organizations and customers quality and product integrity requirements.
Supports product development or operations team by providing analysis and expertise throughout the quality requirements.
Identifies root cause of problems in the production process, recommends and/or implements corrective measures.
Write procedures necessary for implementing quality requirements.
Utilizes DMAIC tools to promote a disciplined non-conformance investigation approach and participates in corrective and preventive actions (CAPA) related activities, including CAPA ownership if appropriate.
Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements.
Promote the use of customer preferred techniques for continuous improvement such as Six-Sigma, Poka-Yoke (Error Proofing), and Measurement System Analysis.
Perform additional duties as assign.
REQUIREMENTS EDUCATION : Bachelor's degree in engineering or any related discipline field (required).
Working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements.
Professional fluency in English is required (B2 - C1), both written and oral.
EXPERIENCE : At least five years of experience in medical device environment is required .
Knowledge of statistical analysis tools and familiarity with equipment and process validation (required).
Proven previous experience working with Minitab (required).
OTHER : Occasional travel to the United States will be required.
A valid U.S. travel visa and an up-to-date passport will be required.
PREFERRED QUALIFICATIONS : Knowledge/previous working experience with ASQ CQE/CSSBB is considered a plus.
Previous supervisory experience is considered a plus.
POSITION SKILLS : Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to write speeches and articles for publication that conform to prescribed style and format.
Ability to effectively present information to top management, public groups and/or boards of directors.
Ability to project manage.
Ability to maintain a professional manner and appearance.
Must be organized and detail oriented.
High level analytical and problem-solving skills.
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