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28 days old

Quality Engineer

Kelly Services
Plymouth, MA 02361
Quality Engineer (Plymouth, MA)


Are you ready, ASAP, for a new role? Have you ever been up a night thinking about your companys manufacturing processes, having great ideas for how you can change them, but, no way to do it? If so this role is for you


Client that machines highly- engineered implants and instruments for surgical applications is currently hiring a Quality Engineer to support Engineering optimizing manufacturing processes.


This is a newly created role and is a Direct Hire.


ABOUT OUR CLIENT:

Product specialties include custom bone screws, bone plates and fixation devices; and perfect-fit complementary, surgical drivers, drill bits, taps and other rotary cutting instruments. They have decades of experience in every aspect of medical machining manufacturing, with specialties in CNC milling, turning, mill/turn and cutter-grinding of all surgical-grade materials, including titanium and other high-performance specialty alloys and plastics.


SUMMARY:

The Manufacturing Quality Engineer is responsible for understanding customer quality related requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day to day support of processes to meet our high standards of precision and quality in producing medical parts


KEY POINTS:

New role due to growth.

This role reports to Engineering Manager, making manufacturing better.

Client machine metals used to make implants.

Very hands -on role with a lot of C.I. initiatives.

Strong mechanical aptitude.

3-5 years.

Medical Device Manufacturing experience is critical.

CNC machinery, metalworking, the need to understand processes associated with machining metal are huge pluses. Theres a lot of post-processing (deburr, painted, etched, etc.). Need someone who has worked with optimizing metal, making things look nice.


DUTIES AND RESPONSIBILITIES:

Understand APQP and PPAP processes and perform project management responsibilities for assigned manufacturing changes or new product launch. Oversee project launch guides from start of purchase order to the finish at PPAP.

Provide Design for Manufacturability feedback to customers and coordinate with customers to implement mutually beneficial design improvements.

Conduct research and development testing and validation to determine process effectiveness and compliance to quality standards.

Develop or revise technical documentation to specify manufacturing processes; including but not limited to documentation of equipment qualification, setup and maintenance procedures (Provide these documents as well as visual controls to the production floor).

Apply knowledge of metrology and GD&T to develop inspection and test methods for a wide array of products and processes.

Develop control plans and sampling plans for the purposes of process control or validation for attribute, and variable data, for lot based and sequential sampling methods, based upon process data and understanding of manufacturing processes.

Develop and implement equipment improvement ideas by reviewing or making recommendations of fixtures, tools and/or other methods to meet productivity and specifications quality standards.

Evaluating existing machinery and processes and researching novel manufacturing and metrology approaches that enhance operator performance, ergonomics, safety, capability, or efficiency of overall production.

Completing cost estimates of implementing new tooling or justification for capital expenditures.

Managing new equipment procurement and setup.

Understand and apply statistical concepts including but not limited to utilization of hypothesis testing, capability analysis, and other methods based on use of normal and non-normal data distributions where appropriate control charting methodologies for various types of data, manufacturing processes, and desired controls.

Confidence intervals and their relation to sampling and appropriate application for given risk levels

Practical application of ANOVA methods for Gage R&R and DoE analysis.

Lead and participate in quality improvement and continuous improvement projects.

Develop/Use Key Process Indicators and statistical methods to determine process effectiveness, areas for improvement, best practices, and lead teams in driving continuous improvement.

Utilize proven lean manufacturing based analytical and troubleshooting/problem solving tools to identify opportunities for quality improvement through defect reduction, cost reduction, lead-time reduction, inventory reduction and elimination of other waste through optimizing floor layout, material flow, and documenting these improvements to manufacturing efficiencies, takt time, floor space utilization and overhead.

Lead/Drive corrective and preventive actions, and effectiveness verification activities for product quality issues.

Work closely with production to ensure necessary controls are enforced for compliance with ISO and FDA requirements, and resources are available to support efficient production.

Prepare reports by collecting, summarizing, and analyzing data from production, quality inspection, and customer feedback to identify trends and recommend updates and changes to processes or systems

Establish and participate in supplier qualification/development activities.

Provide technical troubleshooting/problem solving and training to production employees.

Coordinate and support cross-functional teams, quality, safety, and maintenance.

Contribute to other team efforts to by accomplishing any related tasks as needed to meet business goals.


MINIMUM QUALIFICATIONS:

Minimum Bachelors Degree in an Engineering or Science discipline. Willing to consider alternate Bachelor Degree programs with relevant experience in excess of the requirement below.

Minimum of 2 years of relevant experience in manufacturing capacity.

Working Knowledge of ISO 9000 based requirements and related systems. Preferable is an understanding of GMP for Medical Devices FDA 21 CFR Part 820 Quality System Regulation and ISO 13485 Medical Devices Quality Management Systems or experience working in a regulated industry.

Green Belt or ASQ certification a plus.

Proven problem- solving experience


SKILLS/COMPETENCIES:

Strong interpersonal and presentation skills needed to interact with external customers as well as with all levels within the company.

Must demonstrate excellent writing skills with ability to prepare/review and/or approve technical documentation.

Thorough knowledge and experience surrounding machining and quality inspection.

Proficiency in Microsoft Office Software, and Solidworks a plus.

Project Management and Lean Manufacturing experience.

Good knowledge of statistical tools, ability to manage multiple tasks.

Must be flexible and adapt to changing environments and priorities.

Proven ability to collaborate in a team environment.

Demonstrated entrepreneurial skills with the ability to work effectively in a fast paced and changing environment with multiple priorities.

Excellent communication and interpersonal skills.


OTHER POSITION REQUIREMENTS:

Ability to work in an entrepreneurial, fast-pace and rapidly evolving environment.


\#TJP2022_SPEC


**Why Kelly** **** **Engineering?**


Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-09 Expires: 2022-10-10

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Quality Engineer

Kelly Services
Plymouth, MA 02361

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