Staff Quality Engineer– Quality LCM
Location:
Salt Lake City , Utah
Posted:
March 21, 2017
Reference:
5516170106-en-us

Participate in new product/process teams to develop quality-engineered systems and products, support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.  Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Role will be located in Salt Lake City, Utah. 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

 
  • Primary responsibilities include working in Quality Operations or Quality Engineering and with other functional groups in support of new product/process development. 
  • Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
  • Develop and establish effective quality control and associated risk management plans.
  • Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Direct Failure Mode and Effects Analysis activities for both Design and Process FMEA’s.
  • Provide all planning necessary to ensure effective product acceptance.  This includes, but is not limited to, part qualifications, specification development, and sampling plans. 
  • Support vendor audits as technical lead as needed and support Supplier Quality as Quality Operations/Product Quality representative as appropriate.
  • Participate in MRB review of nonconforming product; recommend disposition and corrective action.  
  • Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
  • Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
  • Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
  • Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.


Qualifications

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:

 
 
  • Bachelor’s degree in a related field,
  • A minimum of 2 years of quality, manufacturing, or research and development work experience in a medical device or other regulated industry is required. 
  • Master’s degree is preferred. 
 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

 
  • American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
  • Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable
  • Ability to develop and implement Quality standards is preferred.
  • Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices is preferred.
  • Thorough knowledge of leading edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is preferred.
  • Ability to apply project management skills to ensure fulfillment of new product development requirements is required.
  • Demonstrated problem solving skills is required.
  • Good understanding of theoretical and practical fundamentals and experimental engineering techniques is preferred.
 

ADDITIONAL POSITION REQUIREMENTS

 
  • Competent using MS Office (word, excel, power point, outlook, etc.).
  • Ability to multi-task and manage multiple assignments in a time manner.
  • Good verbal and written communication skills.
  • Strong interpersonal and leadership skills.
  • Strong analytical skills.
 


Primary Location
United States-Utah-Salt Lake City
Organization
Coherex Medical, Inc. (6226)
Job Function
Quality (Eng)

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