Minnesota - Twin Cities
Senior Quality Engineer – Design & Development (2 positions open)
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 as well as continuation design & development support for sustaining manufacturing and product distribution. 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.
- Product / Process Development activities:
- 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:
- 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.
- Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
- Advanced Degree preferred.
- Minimum of 2-5 years of experience in a regulated manufacturing environment.
- Experience managing/supervising other personnel preferred.
- 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 Design Assurance tools/methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
- 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.
- 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 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.
- 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.
- Product / Process Development activities: