Senior Quality Engineer

6 days ago

Warsaw, United States ATR International Full time

Job Title: Senior Principal Quality Engineer

Type: Contract- 11 Months

Day Shift

Location:2500 Silveus Crossing, Warsaw, IN

Hybrid model with 2 to 3 days a week on site. Also, it will require to travel up to 25% of his time.

Pay: Can Be Flexible



The role of this Quality / Process Eng is to stablish the process control needed for the manufacturing process of Medtronic products.

This role works closely with CNC programmers to stablish the control method to satisfy the print and process requirements

To be able to perform this tasks the candidate shall have the capability of reading blue prints for which a deep understanding of GD&T is required

Also to be able to develop inspection systems with capability of satisfying print requirements and set up SPC to control the process based on historical data


Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.


TECHNICAL SPECIALIST CAREER STREAM:

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.


DIFFERENTIATING FACTORS

Autonomy: Recognized master in professional discipline. Works independently to implement strategic goals and establish operational plans for job area. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results.

Organizational Impact: Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results. Implements strategic goals established by functional leadership. Changes or may establish operational plans for job area with long-range impact on results. Innovation and Complexity: Faces problems that span a wide range of difficulty and unique issues across functions and / or businesses which may cause redirection. Develops solutions to unique issues. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation.

Communication and Influence: Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant matters. Conducts briefings with senior leaders within the job function. Negotiates with others to reach understanding or agreement.

Leadership and Talent Management: Frequently provides guidance, coaching and training to other employees. Typically manages large, moderately complex initiatives of strategic importance to the organization, involving large cross-functional teams


The ideal candidate must possess the following qualifications:


1. Medical device process development and manufacturing, experience of products with electrical functionality an advantage

2. Examples of critical thinking and use of statistics

3. Working in a cross functional teams and leveraging basic PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility within a cross functional team to establish manufacturing lines for medical devices prioritising safety, quality service, cost. Engage with team to understand goals and current reality, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team. Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures. Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, 6M, timeline, Is/Is not, etc. Use statistical techniques to quantify confidence, declare assumptions, be data driven in decision making. Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance). Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges.

4. Overseeing Gage Design

5. Strong GD&T skills

6. Strong SPC acknowledge


Nice To Have

10+ years of experience in implants process manufacturing


Top 3 technical skills that are required for the role:


SPC

GD&T

Measurement Systems development

Process control


Benefits include:

-MEC/ACP Medical

-Voluntary Dental, Vision, Life, Supplemental Income

-401k (must meet requirements)

-sick leave as required by state/county

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