Job ID# 2013000081 and 2013000760
Covidien Location: Boulder, CO
SUMMARY OF POSITION:
- Works together with the R&D, Procurement, New Product Introduction and Engineering organizations related to the family of products under his/her responsibility in order to lead the Supplier Management process from product development to product sustaining activities. Works as the liaison between Covidien Surgical Solutions Division and Manufacturing to ensure the supplier management process results in the highest level of quality products.
- Candidate must have an engineering background including experience in production environment in the medical device field. Strong analytical, written and verbal communication skills are a must. Some travel is required. Applicant must demonstrate the ability to deliver innovative, cost-effective and timely solutions in a multiple project environment.
- Oversees all aspects of supplier quality management from the product families under his/her responsibility by:
- Certifying suppliers based on risk assessments and in accordance with current ISO/GMP/MDD requirements.
- Conducting surveillance audits; complete reports and follow up on any related activities including updating supplier corrective action database, following up and closing corrective actions
- Maintaining supplier audit schedule, and assisting in the maintenance of the supplier files
- Creating and monitoring supplier performance metrics in alignment with business objectives and report on performance to suppliers and management.
- Participating in product development teams to develop plans for new suppliers under the new product Introduction PDP process or the OEM Supplier General Development Plan.
- Leads the certification of new suppliers related to new products by performing risk assessment and initial audit.
- Responsible of transferring new suppliers to GBU facilities no later than the design transfer review or as applicable according to the different supplier quality controls per facility.
- Is the GBU representative for supplier quality corporate initiatives and participates by bringing voice of the customer into the definition of corporate systems and/ or processes.
- Assessing changes that may impact supplied product and services by supporting applicable sustaining development initiatives.
MINIMUM REQUIREMENTS
EDUCATION:
- Bachelor’s Degree in Engineering, Science or technical field.
EXPERIENCE:
- Five (5) years experience in Supplier Quality Engineering; with experience in the Drug/Medical Device industry.
SKILLS/QUALIFICATIONS:
- Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM-Certified Quality Manager, etc.).
- ISO 13485 Lead Auditor Certification
- Experience with measurement system analysis (MSA)
- Quality System Regulation 21 CFR Part 820 training
- 21 CFR Part 11 training
- ISO 17025 training and auditing experience
To learn more, visit Covidien Job 2013000081: Sr Quality Supplier Specialist
Or, visit Covidien Job 2013000760: Sr Quality Supplier Specialist
