Senior Quality Engineer – Product Quality
at HumCap Recruiting

Date Posted: 3/19/2017

Job Description

Description: Must have
-Medical Device Design Control Experience 

-Medical
Device R&D and Manufacturing industries exp

-Regulatory
compliance experience

Job Summary: Provide leadership guidance and analytical skills to facilitate robust manufacturing and evaluation of the company's products to ensure that quality standards are achieved and assure applicable regulatory requirements are maintained, while facilitating continuous improvement and standardization.
Duties & Essential Job Functions:
-Assure compliance to FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, process validation/process improvement
-Perform hazard and risk analyses (DFMEA) for new and existing products
-Perform hazard and risk analyses (PFMEA) for new and existing processes
-conduct complaint investigations related to product design and manufacturing
-Incorporate FDA, ASTM and ISO standards governing sustaining quality standards/principles (ASTM, ASQ, etc.) into inspection and process control methodologies
-Support the coordinated integration of new products into Manufacturing / Operations.
-Assure company's policies, procedures, practices and facility are in compliance with all applicable regulatory policies.
-Provide authoritative guidance about Six Sigma principles (Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, Process and Design FMEA, control charts, capability analysis) to Operations Staff
-Develop department programs / processes to drive continuous improvement and standardization
-Generate process/product quality information in the form of Critical to Quality (CTQ) indices and share with project team/operations any recommendations and proposed solutions to emerging issues.
-Improve KPI metrics within the organization
-Support person for Product Quality during 3rd party inspections

Experience/Skills Required:
•Minimum 12years work experience in a Quality Engineering role, in an FDA-related manufacturing environment, with a history of successful participation in process development, validation and improvement
•Strong working knowledge of 21 CFR Part 820 and ISO 13485
•Understanding of human factors engineering/mistake proofing
•Demonstrated successful application of quality tools including Six Sigma, Lean, and statistics
•Computer literate in various software applications. (i.e. - Word, Excel, Access, Minitab.) Solidworks experience preferred
•Able to read detailed blueprints and follow assembly instructions; GD&T experience
-Machining, casting/forging experience a plus; orthopedic experience preferred
-Ability for occasional travel to local vendors to help resolve quality issues.
-Ability to communicate effectively across various levels of the organization.
-Good writing, data analysis and communication skills.
-Effective skills in analytical thinking including Problem Solving, Root Cause Analysis, CAPA, Change Management, Risk Management and Six Sigma principles

Required Education:
-BA/BS degree. Mechanical Engineering or other technical discipline preferred
-ASQ CQA, CQE or CSSBB preferred

Physical Requirements:
-Lifting requirements- No more than 25 pounds

Job Snapshot

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