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Senior Quality Engineer

4 months ago

Gilbert, United States CooperCompanies Full time

Job Summary

:

Uses Quality Engineering principles – Problem Solving and Root Cause Analysis tools-techniques to develop and optimize systems and processes so that they are aligned with the overall Company strategy. Oversees production processes to assure compliance with company specifications to include QSR and ISO requirements. Reviews, develops, and maintains all associated documentation. Leads and assists in process and product improvement projects. Provides technical input and assistance while adhering to regulatory requirements.

Essential Functions & Accountabilities:

Support and review Design Control activities for new products or process development, including design and development planning, design reviews, design input/output, design verification/validation, design history files, design transfer, risk management, etc. Coordinate the development of product DHF. Utilize risk-based approach to assess and control design and manufacturing changes.  Provide quality engineering support in design and development of medical device products to ensure that quality requirements are translated into product and process functional specifications. Provides technical leadership to support product transfers and launches in compliance with Design Control and other applicable procedures. Develop and/or review of product/process development documentation, software/computer system validation, and process validation documentation. Support the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final, and validation sampling plans as part of the design development process. Lead statistical analysis for sampling plan rationale and analysis, including but not limited to, DOEs, Paretos, ANOVA, and SPC applications. Perform internal and external Audits to maintain Quality System Regulation requirements. Support company goals and objectives, policies, and procedures in compliance with quality manual and quality system processes such as CAPA system, change control, etc. Creates a culture of quality awareness, teamwork, and cooperation with all groups within the facility. Works closely with Regulatory Affairs, Research and Development, Manufacturing, Clinical and other functional groups, to ensure compliance to applicable standards (external and internal) such as ISO 13485, ISO 14971, and FDA QSR/GMP. Examines work for thoroughness, exactness, neatness and conformance to policies and procedures. Investigates instances of nonconforming material and facilitates the determination of root cause and corrective action/preventive action. Leads teams responsible for the improvement activities Participates in supplier approval and evaluation and leads supplier improvement efforts. Coordinates calibration and training requirements for the department.  Other duties as assigned.

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Travel: Travel will be limited but may include both domestic and international destinations

Qualifications

Knowledge, Skills and Abilities:

Must have experience with Internal Auditing in a Medical Device field. Audit Training certifications preferred. Technically sound in quality systems and be abreast of developments in the Quality Assurance field. Including practical application of ISO 13485 and FDA Quality System Regulation 21 CFR part 820. Must possess the ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Able to write reports, business correspondence, and procedure manuals. Possess the ability to effectively present information and respond to questions from groups of senior managers and the public. To be successful in this role the individual must be able to work with mathematical concepts. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Must possess the ability to interpret a variety of instructions furnished in written, oral or diagram format. Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma GB or CQE preferred. GCP or GMP experience is a plus. Self-starter and able to work both independently and as a leader of an integrated, interdisciplinary team in carrying out assigned responsibilities. Excellent interpersonal and written communication skills to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing. Proficient in Microsoft Office tools.

Work Environment:

Office working environment Use of computer systems The employee may be intermittently exposed to moderate noise levels. Must be able to travel periodically to perform external Audits

Experience:

Minimum of 8 years’ experience as a Quality Engineer, or similar role in the medical device field.

Education:

Bachelor in an Engineering or Science discipline or equivalent combination of education and experience.

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

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