Quality Engineer III

ID# DCCA27285

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW

SUMMARY:

 To conduct the Quality Assurance activities associated with supplier and contract services, including raw materials, components, packaging material, manufacturing/packaging locations, licensing partners, testing laboratories, affiliate locations, and/or acquisitions. 

KEY SKILL / KNOWLEDGE REQUIREMENTS: 

SKILL SETS 

  • Management and leadership skills 
  • Business acumen 
  • Manufacturing, Quality, and Process Excellence knowledge 
  • Interpersonal and influencing skills 
  • Financial knowledge 
  • Statistical and Goal Setting ability 
  • Cultural appreciation and diversity 

REASONING ABILITY 

  • Ability to make sensible decisions that effectively support business and company policies and requirements, and uphold the Credo values. 
  • Ability to assess risk and exercise good judgment at all times. 
  • Unyielding standards of honesty and integrity. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. 

  • Work closely with external manufacturers and suppliers to ensure compliance with external supplier and contract manufacturing/packaging and testing support services requirements. 
  • Qualify suppliers through vendor surveys and audits. 
  • Conduct raw material and component qualifications at suppliers, pursuant to BWI’s and compnay's requirements. 
  • Administer regulatory requirements and compnay Policy and Standards to ensure external manufacturers and suppliers satisfy both BWI’s business and compliance requirements. 
  • Work closely with the BWI Supply Chain team and Suppliers to ensure suppliers’ performance consistently satisfies BWI’s quality, compliance, and operational requirements. 
  • Drive Six Sigma and process excellence activities at the Supplier, including the identification of key CTQs, and analyzing supplier performance. 
  • Serve as a member of the BWI Supplier Management Team (SMT). 
  • Write, review, approve and/or execute new Quality standards, and make changes to existing documentation. 
  • Develop/modify and implement supplier compliance and excellence program. 
  • Provide technical support for supplier continuous improvement initiatives (SPC, Gage R&R, etc.), and help transition qualified suppliers to improved platforms of delivery and compliance assurance (i.e., dock to stock, VMI, supplier kanbans, etc.). 
  • Initiate supplier corrective action requests, and analyze received corrective actions to ensure they are viable and adequately address the root cause of non-conformance. 
  • Collect data, create reports, and distribute supplier performance metrics. 

QUALIFICATION AND REQUIREMENTS:

 To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

EDUCATION and/or EXPERIENCE:

  • 5-7 years prior manufacturing, technical, or business background, must have Bachelors Degree or equivalent combination of education and work experience. ASQ CQA or other certification is a plus. 
  • Ability to use broad knowledge of regulatory, technical, and business requirements to conduct supplier audits. 
  • Ability to apply project management skills to ensure fulfillment of contractual agreements, and corrective actions. 
  • Ability to develop and implement Quality standards. 
  • In-depth knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices. 
  • Demonstrated auditing, problem solving, and process improvement skills. 
  • Understanding of Six Sigma and lean manufacturing tools and methodologies. 
  • In-depth knowledge of leading edge Supplier Quality Management approaches. 
  • Demonstrated verbal and written communication skills, and ability to effectively communicate with internal and external personnel at all levels of the organization. 
  • Well-developed influencing skills---ability to effectively train and mentor a diverse array of employees. 
  • Good business and financial acumen. 

 

 

 

Position Details:

Medical Device

Engineering

Start Date: 
9-23-2013
End Date: 
12-31-2013

IRWINDALE, CA

CON_W2

40

DCCA27285

No

No