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Quality Assurance Engineer - Medical Device (Fulltime/Permanent - Direct Hire)

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Company: Coyote Technical & Executive Sourcing

Location: Immaculata, PA

Date Posted: April 24, 2014

Source: Coyote Technical & Executive Sourcing

Job Title: Quality Assurance Engineer

Department: Quality Assurance

Reports To: Quality Engineering Supervisor

OVERALL RESPONSIBILITIES:

Develop, implement and maintain Quality System requirements on assigned areas of Manufacturing, Supplier management, Process Validation and New Products Introduction. Areas of responsibility may include: Non-conforming product, CAPA, Calibration Systems, Supplier Auditing, Sterility, Measuring techniques, Design of tools and gages, Training, Statistical Support, Quality Planning, Experimental Protocols, Facilitation of Root Cause analysis, Risk Assessment and Complaint Investigation.

POSITION DUTIES & RESPONSIBILITIES:

General

: Know and follow all laws and policies that apply to one's job and maintain the highest levels of professionalism, ethics and compliance at all times.

: Diligently participate in our compliance program- related activities as denoted by your supervisor or our Chief Compliance Officer.

: Perform other related duties as required.

The Quality Engineer assignments can be isolated but not limited to the following tasks:

Manufacturing Support

: Member of the Material Review Board (MRB). Communicate ...

Job Title: Quality Assurance Engineer

Department: Quality Assurance

Reports To: Quality Engineering Supervisor

OVERALL RESPONSIBILITIES:

Develop, implement and maintain Quality System requirements on assigned areas of Manufacturing, Supplier management, Process Validation and New Products Introduction. Areas of responsibility may include: Non-conforming product, CAPA, Calibration Systems, Supplier Auditing, Sterility, Measuring techniques, Design of tools and gages, Training, Statistical Support, Quality Planning, Experimental Protocols, Facilitation of Root Cause analysis, Risk Assessment and Complaint Investigation.

POSITION DUTIES & RESPONSIBILITIES:

General

: Know and follow all laws and policies that apply to one's job and maintain the highest levels of professionalism, ethics and compliance at all times.

: Diligently participate in our compliance program- related activities as denoted by your supervisor or our Chief Compliance Officer.

: Perform other related duties as required.

The Quality Engineer assignments can be isolated but not limited to the following tasks:

Manufacturing Support

: Member of the Material Review Board (MRB). Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions.

: Work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams.

: Provide quality reports and review trending on assigned areas of responsibility.

: Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs).

: Review and approve documents and drawings for manufacturing and product development (DCOs, MCs).

: Support to Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of new and existing products.

: Develop training course materials and conduct training for approved documentation and practices.

New Products

: Participate on cross- functional project teams.

: Design gauging and develop tools and techniques to measure pertinent product parameters to assure product complies with engineering drawings.

: Recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities.

: Develop and document Quality Plans to support new products.

: Facilitate creation of PFMEA.

: Ensure compliance issues are addressed for new products activities.

: Participate on design reviews and risk analysis for new products.

Validation

: Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness.

: Review, assess and evaluate validation protocols (IQ,OQ,PQ) for compliance to procedures and regulations, statistical validity and approval.

: Provide guidance to others for the generation of clear, concise and defendable protocols and reports.

: Assist in determination of the need for validation.

: Generate and/or maintain internal validation master plans as required.

: Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting.

: Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s).

: Lead continuous improvement activities for the validation program to ensure efficiency, effectiveness and compliance.

Supplier Management

: Coordinate and participate on supplier audits and technical assessments.

: Assist purchasing with identification and qualification of suppliers and alternate manufacturing locations.

: Administrate Supplier Management Program and measures effectiveness.

: Manage Supplier CAPA activities including root cause analysis, definition of corrective actions and verification of actions.

: Coordinate Quality Plans and inspection/test methods between suppliers and the company.

: Visit suppliers for the purpose of quality issues investigation and capability analysis.

: Assist purchasing in resolution of supplier complaints.

PROFESSIONAL EXPERIENCE & EDUCATIONAL REQUIREMENTS:

: BS degree in Sciences, Business, Engineering or related technical field.

: Experience in the medical and/or pharmaceutical field. Two (2) years QE experience preferred.

: Knowledge of FDA's QSR and ISO regulations preferred.

: Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development.

: Strong Statistical ability and experience including Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments.

: ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification preferred.

: Demonstrated excellent interpersonal and communication skills.

: Working knowledge of Word Processing and Spreadsheet software required (MS Word and Excel knowledge desired).

: Knowledge of Manufacturing materials and processes preferred (machining, sheet metal, electropolishing, passivation, hard coating, anodizaton, etc.)

: Attention to detail and ability to meet deadlines. Ability to manage multiple projects/requirements in a fast-paced environment.

: Ability to work independently with minimum supervision for application of QE principles and Techniques.

: Ability to work effectively in a team environment.

DEVELOPMENT CENTER ONLY REQUIREMENTS:

: Knowledge of Manufacturing Clean Rooms, ISO Class 7 and ISO Class 8 (Class 100,000 and 10,000).

: Strong environmental monitoring knowledge for Clean rooms.

: Experience with Biomaterial, Ceramic and Polymer medical devices is a plus.

: Strong Pharma/Medical Device Manufacturing and R&D experience.

: Knowledge of sterile packaging and sterilization validations.

No sponsorship visa (H1-B, etc) candidates at this time, sorry.

Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:

COYOTE TECHNICAL & EXECUTIVE SOURCING

Phil Montoya

Director of Sourcing

220 Miracle Mile, Suite B219

Coral Gables, FL 33134

P: 832-266-1610

Fax: 305-520-0138

phil@coyotesourcing.com

www.coyotesourcing.com

Like us on Facebook www.facebook.com/CoyoteTech

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For more job openings, please visit http://www.coyotesourcing.com...

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