25 Sep Design & Development Quality Engineer
SUMMARY:
Essential responsibilities of the Design & Development Quality Engineer are activities associated with Design Control and Design Quality Assurance during the Product Design and Development Process. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.
Reporting Relationships:
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- The Design & Development Quality Engineer position reports up to the Principal Engineer / Quality Engineering Manager / Site Leader of Quality.
- This position may have direct-reporting and/or supervisory responsibilities for daily activities of Contract Personnel and/or Quality Technicians (responsibility dependent on geographic organizational structure).
Responsibilities:
Product / Process Development activities:
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- Author and execute Quality Plans for Product Design and Development projects.
- Initiate and/or consult in the development and/or update of Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
- Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
- Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
- Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
- Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
- Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
- Represent Quality Engineering in design and phase reviews throughout the product development process.
Ensure FDA and ISO Compliance in all areas:
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- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
- Provide statistical data / trending analysis on CAPA, NMR and other quality metrics.
- Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
- Strong verbal and written communication skills, including technical report writing
- Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
- Other duties as assigned.
Qualifications:
Education:
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- Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
- Advanced Degree preferred.
Technical:
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- Minimum of 3 years of experience in a regulated manufacturing environment.
- Experience with metal stamping processes.
- Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
- Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
- Design Controls / DFx / DFm / DFr knowledge and experience preferred.
- Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.
Skills:
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- Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
- Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
- “Hands-on” self-starter with ability to work both independently and as part of a team.
Training:
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- Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
- Experience with statistical software tools (i.e. Minitab) experience preferred.
- Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.
Expectations:
Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
Initiative: Capability to function independently without supervision.
Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
Team Player: Must be able to work and thrive in a team environment.
Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
Please click here to apply or email CareersAtCirtec@Cirtecmed.com
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