Quality Engineer Product Development

SHREEL SHAH

FULLERTON CA

714-***-****) ******.********@*****.***

Qualification and Skills

- Highly Skilled and motivated Quality Engineer with Several years of Experience in new product Development and

manufacturing experienced in Mechanical and Electro-Mechanical Parts and Instruments.

- Conduct Nonconformance Investigation on mechanical parts/components to determine root cause of failures. Maintained

quality standards compliant with ISO 9001:2008 policy.

- Knowledge of 21 CFR section 820 and ISO 13485

- Well versed with remediation of Design History Files (DHF) of various medical implants and instruments to comply

with 21 CFR 820.30 (Design Control) FDA Quality System Regulations (QSR)

- MDR submission experience.

- Evaluate Nonconformance Investigation and make CAPA determinations.

- Experience with complaint handling, quality systems, regulatory affairs and complaints handling.

- Experience with managing customer complaints in a database of sorts.

- Expert in Problem-solving methodologies and tools (PDCA, Six Sigma, Lean Manufacturing, Pareto Principal, 5s,5why’s,

8D, Ishikawa/Fishbone).

- Extensive Knowledge of Quality Systems, design transfer, risk management, production & process controls, measurement

system analysis and performs audits.

- Experience in statistical analysis methods i.e. SPC/Six-sigma. Familiarity with various Root Cause Analysis tools i.e. DMAIC,

5 Whys, etc.

- Knowledge of effective supplier evaluation techniques to identify failures using root cause analysis, (CAPA) corrective

action delivery and preventative measure implementation.

- Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as: DOE, ANOVA.

- Expertise in Process Validation, Test Method Validation, Design Control Activities, worked on end of life change controls,

DHF Remediation.

- Experience implementing documentation, test procedures, and formal Validation & verification procedures.

- self-taught & trained to company Quality Management Systems and used to with work instruction /SOP’s.

- Inspection of parts using various instruments like micrometers, Vernier, height gauges, slip gauges, bore gauges.

- General knowledge of manufacturing processes such as injection molding, assembly, packaging.

- Ability to successfully complete projects and tasks on time and meet deadline. Dedicated to quality work and attention to

detail; clever work ethic.

- Demonstrated ability to work effectively as part of team and independently. Goal Oriented and dedicated to achieving

results. Creative Problem Solver, motivated, self-starter and highly organized.

Education Qualification

Master of Science in Mechanical Engineering, California State University, Los Angeles.

Bachelor of Engineering in Mechanical Engineering, North Maharashtra University, India.

Additional Information

Engineering: Product Design and Development, Control of Mechanical Systems, Machining Science and Application, Test Method Development, Advanced Mechanical Particles, Forensic Engineering.

Standard Used: ASME Y14.5, ISO 9001, TS16949, ISO14001,

Ideal Skills: Analytical, Critical thinking, Attention to detail, Numerical skills, Strong Communications and Presentation skills, Team-work & Leadership, Negotiation skills, Creative thinking and excellent problem-solving skills, Planning & Organizing, Analyzing Quantitative Data, Decision Making, always punctual, easily adapts, Friendly personality.

Professional Experience

Astrophysics Inc., City of Industry, California (Sept 2017 – Present)

Production/Imaging Tech.

- Responsible for the assembly of the mechanical and electrical components of security x-ray machines.

- Assemble equipment according to plans, manuals or drawings to meet quotas and deadlines.

- Dismantles, adjust, and assemble equipment according to plans, manuals, or drawings.

- Identifies and resolves problems in a timely manner.

- Continuously looks for ways to improve work processes.

- Troubleshoot all kinds of problem which cause in machines. Set Diode plot for better Imaging.

- Responsible for reducing radiation with help of radiation meter.

Cardiomac India Private Limited (Jul 2013- Aug 2015)

Quality Engineer

- Lead Material Review Board (MRB) meetings and establish a corrective action plan for internal rejections, customer

rejected product, and customer issued corrective actions

- Interface with customers pertaining to quality requirements or product nonconformance.

- Perform root cause analysis utilizing such concepts as 5 Whys, 8D, and fishbone diagram.

- Implemented 5S methodology in the quality department and production floor to visualize and standardize the contract

review and corrective action processes, and to identify acceptable Foreign Object Debris levels.

- Write, review, and file Medical Device Reports and potentially Vigilance Reports as required. This includes on-time filing of

initial and supplemental regulatory reports.

- Write quality processes for complaint handling or complaint summaries for complaints that have previously been

investigated

- Interface with customer Field Quality Engineers during FAIR and Source Inspection processes.

- Perform follow-up activities to gain additional information in accordance to standards, procedures and regulations.

- Perform complaint management and reporting activities that include device assessments and submissions, complaint coding, dispositions.

- Perform complaint data horizontal analysis as requested per functional groups.

- Processing complaint events as required per internal and FDA regulations/International standards

- Monitoring and tracking key operational data trending

- Analyzes clinical data, performs testing on filed complaints that may include customer returns.

- Provide training on complaint handling for new employees and cross functional teams

- Providing product complaint analysis, audit support(CAPA)/NCR, managing multiple quality improvement projects and

providing quality systems support

- Design process - creating and managing the design and risk control documents within the Product Development Process.

Creating the verification and validation protocols and technical reports.

- Maintaining engineering drawings and specifications required for manufacturing of the specialty and prototype instruments.

- Design data management creating and managing the Design History Files (DHF) and appropriate Device Master Records

(DMR) within the Specialty Instruments Product Development Process.

- QA and RA requirements - managing the necessary approvals and required documentation.

- Delivery System Product Development Projects, involve in FMEA risk management workbook, Internal Audits, CAPA and

validations for Packaging.

- Prepared Supplier Corrective Action Report (SCAR) and developed Supplier Metrics to determine the performance and quality of suppliers.

- Reviewed and wrote validation protocols.

- Nonconformance, Corrective and Preventive Actions management according company’s procedures. Involved in new

project developments.

Shailesh Surgical (Jan 2012- Jun 2013)

Quality Engineer

- Responsible for hands on quality assurance efforts, maintaining regulatory compliance, and CAPA/NCR investigations.

Plan and ensure/comply internal design control policy, regulatory, and external standards implementation at each stage of

product development life cycle.

- Performed root cause investigations, complete with fishbone analyses. Evaluate customer returned equipment to determine

root cause for Complaint Investigations

- Manage the Quality operations functions, including inspection testing of sub-assemblies and finished products, process

control, system verification, review of documentation, management of computer programs and its applications related to

the product line under responsibility.

- Worked with product development and vendors to change processes/products for manufacturability.

- Worked as a coordinator between suppliers and internal functions/plants (Engineering, Plants, Operations, etc.)

- Perform risk management activities (Hazard Analysis Use FMEA).

- Review of design and development documentation for functional, manufacturing, V&V, and quality characteristics.

- Using SPC, DOE, ANOVA, Six Sigma, Quality Control methodologies, gauge R&R, and Advanced Statistical methods in

product design, test method development, test sample selection, and test data analysis.

-Lead, interact, guide/mentor, and form constructive working relationships with all levels of leadership within Marketing,

R&D, and Quality.

- Utilized advanced statistical analysis techniques to determine product acceptance against product specification and user

need requirements.

Certification Technical skills

SOLIDWORKS (Certified Dassault Systemes SolidWorks Corporation) ● AUTOCAD

Six Sigma Green Belt (Certified by International Six Sigma Institute) ● SOLIDWORKS

Six Sigma Yellow Belt (Certified by International Six Sigma Institute) ● MS OFFICE

3D modeling and printing (Certified by Lynda) ● MINITAB

Learning Minitab (Certificated by Lynda)

AFFILIATIONS

Member - American society of Mechanical Engineers (ASME)

Society of Automotive Engineers (SAE)

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