Manager, Supplier Quality Engineering

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

Lead the supplier quality team and coordinate efforts to evaluate, select, qualify, rate, monitor and improve supplier quality.

 

Job Responsibilities and Essential Duties

• Collaborate with the supply chain management team, quality control, engineering and regulatory to establish guidelines for supplier quality and performance.
• Ensures that supplier quality personnel maintain the required skill level to address compliance issues and to understand the technical aspects of compliance. 
• Responsible for ensuring that training is completed for direct reports and database is up to date.
• Develop risk based programs for supplier qualifications and supplier performance and productivity improvement.
• Develop strategy for continuous supplier quality improvement.
• Create benchmarks to measure department performance.
• Create reports that measure and track supplier quality performance to identify opportunities for supply chain improvements.
• Oversees supplier rating program.
• Participates in team project meetings for new product development.
• Plays a major role in the supplier selection process, evaluation of potential suppliers and the supplier qualification process.
• Manages supplier audit program and participates as needed. 
• Oversees audit/assessment of current and future suppliers ensuring they are compliant with requirements.
• Oversees validations and qualifications of supplier facility to qualify manufacturing processes and overall quality of part/component manufacturing.
• Contributes to team effort by accomplishing related tasks as necessary.

 

Minimum Requirements

• Bachelor Degree in Engineering, Scientific or related discipline, or equivalent work experience.

• A minimum of six progressive years’ experience in a supplier quality role or equivalent position. 

 

Required Knowledge, Skills and Abilities

• Experience in the areas of lot acceptance sampling methodologies, MSA/GR&R, SPC and other statistical techniques.
• Demonstrated knowledge of business impact, compliance issues and risk management. 
• Good project management ability.  
• Familiarity with CAPA Systems and working knowledge of applicable regulations and standards such as FDA QSR, ISO, ROHS, WEE, REACH and MDD. 
• Audit experiences a must.  Previous supervisory experience required.
• Six Sigma and ASQ certification (CQE, CQA) highly desired. 
• Strong skills in negotiation and influencing decision makers, as well as judgment, tact and leadership ability.
• Strong computer skills with proficiency in MRP systems.
• Experience with an ERP system and/or ERP implementations and Oracle would be a plus. 
• Excellent working knowledge of MS Office (Word/Excel) and a statistical based software package (Minitab preferred). 

 

Supervision/Management of Others

• Supervisory Skills – The ability to coach, develop and motivate associates to optimize team effectiveness. 
• Ability to impact team morale, sense of belonging and participation.

 

Internal and External Contacts / Relationships

• Various

 

Quality Requirements

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

 

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices a