Job Overview
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This role is responsible for ensuring quality and risk management throughout the lifecycle of new product development projects.
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The individual will represent quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation.
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Key Responsibilities:
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* Represent quality interests and concerns on project teams.
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* Lead risk management activities and own Quality engineering activities for NPD projects.
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* Balance multiple projects and tasks from product inception through product launch and maintenance.
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* Review design control compliance requirements for NPD projects and all design elements.
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* Develop UFMEA & DFMEA and coordinate guidance from other design sub-team members.
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* Perform DOE's and statistical analysis to support product and process optimization or resolve causes of process variation.
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* Initiate corrective actions as required.
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* Support assessment of biocompatibility testing required as per ISO10993 and company procedures.
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* Participate in internal audit and supplier audit programs.
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Requirements
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Third-level Engineer / Technical / Science Qualification
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Minimum 5 years experience in medical device or pharmaceutical industry desirable
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Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR
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Attention to detail and adaptability
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Dedication to excellence and flexibility
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Problem-solving techniques with excellent organization skills
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Excellent interpersonal skills with ability to work in team environment and work under own initiative to target and deadlines
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Benefits
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At BD, we are committed to investing in our associates' well-being and development, and providing rewards and recognition opportunities that promote a performance-based culture.
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We offer a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
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Other Information
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BD is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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