Principal Quality Engineer

3 weeks ago

New York, United States CareerBuilder Full time

Primary Job Responsibilities / Skills
Lead quality engineering initiatives to meet organizational goals.
Offer guidance and direction in the formulation and assessment of validation policies, schedules, and protocols, as well as quality engineering matters. Demonstrate effective leadership or collaboration within quality-related decisions and practices.
Assist in enhancing process quality and testing procedures within the engineering department.
Provide technical proficiency in risk documentation processes.
Lead or participate in investigations concerning manufacturing non-conformities, product/component failures, customer complaints, or product returns. Conduct technical troubleshooting, FMEA, hazard analysis, root cause determination, and recommend CAPA solutions.
Contribute to non-conformance investigations, responses, and corrective action plans as necessary.
Provide direction and expertise in statistical methodologies, risk analyses, and other quality engineering tools.
Support supplier qualification efforts and collaborate with relevant departments on SCRs.
Lead design process characterization studies (DOE, R&R); analyze results statistically to identify critical parameters and enhance process capability.
Participate in Design Control New Product development teams. Offer guidance on design control requirements and review and approve related quality engineering and validation deliverables.
Perform other duties as assigned.

Requirements
Education & Training:
Bachelor's degree in Engineering or related sciences preferred.
Advanced degree is advantageous.
Certified Quality Engineer (CQE) or equivalent certification preferred.

Experience:
Minimum of five years' experience in validation and/or quality engineering within the medical device industry, including practical application of FDA Quality System Regulation and ISO 13485, or equivalent combination of education/experience.
Prior experience with class II or III medical devices
Understanding of manufacturing processes such as injection molding, assembly, packaging, and sterilization is essential.
Knowledge of international/ISO standards in ophthalmology is advantageous.
Familiarity with regulatory/compliance/validation matters is required. Candidates should be self-motivated, intelligent, and dependable.

Skills:
Excellent project management, organization, writing, communication, and presentation skills are essential.
Ability to communicate effectively across various styles and influence consensus among cross-functional groups.
Proficiency in technical writing, especially compliance and/or Validation/quality assurance documents and protocols, is necessary.
Familiarity with basic quality tools for formatting, trending, and presenting information (e.g., scatter plots, histograms, Pareto diagrams, flow charts, SPC, FMEA, Fault Tree Analysis) is required.
Proficiency in compiling, analyzing, graphing, and comparing data using standard statistical techniques (e.g., t-tests, ANOVA, linear regression analysis) is essential.
Demonstrated expertise in Windows-based software, including Word, Excel, Access, Project, and PowerPoint.
Proficiency in written and spoken English is required.

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