Senior Development Quality Engineer

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We are seeking an Engineer - Degreed II for a very important client.

We are seeking a Senior Development Quality Engineer to join our SH team in either our Saint Paul, MN or Plymouth, MN location.
The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system.?
This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects and lead completion of design control deliverables.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Primary Duties and Responsibilities:
? Lead on-time completion of Design Control deliverables?
? Create and ensure on-time execution of?Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
? Accountable for Design Verification and Validation planning and execution, including active cross-functional?root-cause analysis investigation and resolution activities
? Lead Risk Management activities, including analyzing field data to support new product development, and?supporting Failure Mode Effects Analysis?
? Support design test and inspection method development, and lead method validation activities
? Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps
? Support manufacturing process development and qualification for new product commercialization and product changes
? Support internal and external audit responses and on-time product re-certifications
? Support and ensure the establishment of objective, measurable, discrete, and verifiable?customer and product requirements
? Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications?
? Support the development and review of?biocompatibility and sterilization validations
? Supports R&D product builds for bench testing, animal lab, and first in human activities.
? Complete Document Change Request Reviews in a timely and objective manner
? Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
? Develop and lead other team members.

Other Duties:
? Additional duties may be identified by functional management based on the current project/business objectives.
? Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

This position will support a new product development project and lead completion of design control deliverables. The project will be a new development program, following our phase gate process. Initial work will be related to the Design Input Phase Review, then moving into the Design Selection Phase. Primary work will include test method validation, writing design verification protocols, coordinating sample builds and testing, analyzing test results, writing design verification reports, updating FMEAs and other risk documentation and maintaining traceability documentation. Key Responsibilities: ? Core team member ? responsible for all DQ deliverables and compliance to the design control requirements. ? Keep track of deliverables as they are coming due and what is coming down the road weeks and months out ? Assign deliverables to other engineers ? Lead an extended Quality team meeting with cross-functional team members ? General DQ tasks: Risk Management (RMR, dFMEA, uFMEA), Design Verification Testing, Design Validation Testing, Development Test Method Validation. For DV/DVal testing, this includes writing protocols, managing test sample builds, coordinating testing with testing technicians, analyzing results and writing reports
Requirement:
The ideal candidate will possess the following qualifications:

Required Qualifications:
? Bachelor?s degree within an Engineering field or related science-based discipline
? 5-8 years of related work experience
? Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
? Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
? Ability to work in a highly matrixed and geographically diverse business environment.
? Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
? Ability to leverage and/or engage others to accomplish projects.
? Multitasks, prioritizes and meets deadlines in timely manner.
? Strong organizational and follow-up skills, as well as attention to detail.
? Ability to travel approximately 10%, including internationally.
Preferred Qualifications:
? Advanced degree in a technical field
? Medical device experience, specifically with valves and /or implantable devices
? Experience working in a broader enterprise/cross-division business unit model
? Prior experience working with any or all of the following:
? ISO 13485 Medical Devices ? Quality Management System
? 21 CFR Part 820 FDA Quality System Regulations
? ISO 14971 Medical Devices ? Application of Risk Management
? EUMDR
? MDSAP
? Good Manufacturing Practices And Good Documentation Practices

Possesses educational qualifications and work experience as established by engineering schools, employers and licensing authorities for employment in the various disciplines of engineering, i.e. Mechanical, Electrical, Industrial, Manufacturing, Chemical etc. Experience level: 3 - 5 years

Preferred Qualifications:
? Advanced degree in a technical field
? Medical device experience, specifically with valves and /or implantable devices
? Experience working in a broader enterprise/cross-division business unit model
? Prior experience working with any or all of the following:
? ISO 13485 Medical Devices ? Quality Management System
? 21 CFR Part 820 FDA Quality System Regulations
? ISO 14971 Medical Devices ? Application of Risk Management
? EUMDR
? MDSAP
? Good Manufacturing Practices And Good Documentation Practices

Key Requirements:
1) Core team experience
2) Problem solving and CAPA experience. Ability to analyze problems and come up with creative solutions. Lead root cause investigation meetings.
3) Great communication/leadership skills. Able to work cross functionally.
4) Great documentation writing skills.
5) Testing coordination experience
6) Protocol development experience.
7) Report writing experience. a. Must have good attention to detail b. Able to conduct data analysis and apply statistical technics to data c. Be able to clearly document what was done and justify any deviations to the protocol
How to Apply:
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