Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Validation Quality Engineer

Expired Job

Pddn INC Raynham , MA 02767

Posted 4 months ago

Role: Validation Quality Engineer
Location: Raynham, MA
Emp Type: Permanent Job
Interview: Phone/Skype

A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 3-5 years related experience.

Experience working in both an FDA and European regulatory environment is preferred.

In-depth knowledge of product/process Risk Management (FDA and ISO standards)

Technical training and experience using Statistics, Lean and Six Sigma Methodologies

Good technical understanding of manufacturing equipment and processes is required.

  • Good experience validations (IQ/OQ/PQ) Understanding of different types of metal/plastic cutting manufacturing processes- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.

  • The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.

  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.

  • Demonstrated project management and project leadership abilities are preferred.
    Business Improvements

Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

Conduct benchmarking to develop more effective methods for improving quality

Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. Compliance/Regulatory

Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.

Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.

Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate. Product Quality, Control & Disposition and Performance Standards

Supports activities related to the Material Review Board.

Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification

Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans

Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.

Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.

Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

Develop, interpret and implement standard and non-standard sampling plans

Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.

Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits. Risk Mitigation

Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs

Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements Strategic

Ensures effective quality strategies are created for the validation of test methods, process and design.
validation, IQ, OQ, PQ,TMV or Software Validation

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Design Quality Engineer

Kelly Services, Inc.

Posted 3 days ago

VIEW JOBS 12/11/2018 12:00:00 AM 2019-03-11T00:00 Kelly Services is seeking qualified candidates for a direct hire Design Quality Engineer position in Raynham, MA. OVERALL RESPONSIBILITIES: Working in the Design Quality team the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills. Candidate will support efforts to ensure EU MDR compliance. Must have a strong compliance background and experience with Medical Device Regulations. POSITION DUTIES & RESPONSIBILITIES: * Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements. * Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports. * Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting. * Revise, review and approve verification and validation activities as required. * Review and approve any required drawing updates, including design impact assessments. * Review and approve any labeling updates, including design impact assessments. * Deliverables to be quarterly based on assigned files. * Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required. * Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions. * Provide leadership in the understanding of medical device regulations to other disciplines. * Ability to work in a team setting within Design Quality and cross-functionally is required. * Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing. * 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. * Report task progress and status on a weekly basis. EDUCATION & EXPERIENCE REQUIREMENTS: * A minimum of Bachelor's degree in engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field are required. * Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management are required. * Proven track record implementing Quality System improvements to meet compliance and overall business goals. * Change control experience (reviewing and approving design engineering change orders through a PLM System) is required * Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.) is required. * Candidate should possess excellent problem solving, decision-making, and root-cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations. * Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers. * Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred. * Previous experience in a medical device or a healthcare discipline is preferred. * Previous Quality Engineering experience is preferred. * Working knowledge of material science and mechanical product knowledge is preferred. * Development and/or manufacturing experience is preferred. * Blueprint literacy including GD&T is preferred. * Knowledge of process and design excellence tools is preferred. * This position will be based in Raynham, MA Kelly Services, Inc. Raynham MA

Validation Quality Engineer

Expired Job

Pddn INC