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    Design Quality Engineer - Irvine, United States - Diverse Lynx

    Diverse Lynx
    Diverse Lynx Irvine, United States

    1 week ago

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    Description


    Relevant Experience (in Yrs) 5+ years of experience & demonstrated proficiency in Design Quality & providing ongoing technical support is preferred with evidence of continued self-development.

    Work experience in the Medical Device industry.

    Technical/Functional Skills GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs Strong creative, analytical and problem-solving skills.

    Proficient at interpreting data and putting that data into a report Proficient at statistical analysis Experience in EU MDR or other regulatory related projects Verification and Validation CAD Support (Preferred Auto CAD and Solidworks)

    Experience in creating PFMEAs & Writing reports Process experience, ability to observe and understand manufacturing processes Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred Personal computer skills, Windows:
    word processing, presentation, e-mail, web browsers & spreadsheet software Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)

    Roles & Responsibilities Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the duties and responsibilities for this position are:

    Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment Continually seeks to drive improvements in product and process quality.

    Implement, maintain and update procedures that ensure that R&D documentation constantly meets the Product Development Process and Design Control requirements.

    Participates in Risk Management activities throughout product lifecycle Perform quality activities (risk management, FMEA, creation of documents, document review) according to project schedule Use statistical and risk management techniques for design and manufacturing and medical device industries Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.

    Identifies and resolves complex exceptions to work assignments. Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings. Build Quality into all aspects of work by maintaining compliance to all quality requirements.

    Keeps up to date on all ISO/EN/FDA/MDD/ MDR and other Product Development related regulatory requirements and relay this information to the Product Development group.

    Co-ordination of team activities in line with departmental objectives and project goals Supervision and development of staff reporting to them in line with departmental and project goals.

    Coaches' others in analysis and decision making.

    Provide guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with BSC policies and procedures.

    Can Lead and Manage Team at onsite/offshore Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination.

    All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role.

    We promote and support a diverse workforce across all levels in the company.
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