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Quality Engineer FL Open (J#25510)
Education: Bachelors Degree
Experience: 4 - 9 years

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Whatever your specialty or ambitions, you can make a difference at Covidien both in the lives of others and your career.

We are an affirmative action/equal opportunity employer.

Position Summary

This position participates in the quality engineering functions within the manufacturing facility by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. This person is in a direct leadership role and may serve as the Deputy Quality System Management Representative in the absence of the Quality Manager.

This position works directly with Manufacturing, R&D and Engineering to assure quality considerations are adequately covered in the design, testing, and release of materials, components and completed products. Position is expected to have an expert level understanding of FDA regulations and ISO 13485, MDD and CMDR requirements; provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems.

Participation in internal audits, supplier audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions.

Position maintains primary responsibility for critical quality systems as delegated by the Quality Manager, which can include the internal audit program, CAPA system, environmental monitoring, and OEM customer support. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards.

1. Serve as direct backup to the Quality Manager (Quality System Management Deputy) during timeframes when the Quality Manager is unavailable or out of the office.
2. Serve as an internal expert on the interpretation and application of FDA 21 CFR Part 820 and ISO 13485
3. Supervise Quality Coordinators, Quality Technicians and other temporary quality assurance workforce.
4. Responsible for seeing that all tasks are performed in a manner that complies with Covidien / Total Quality Management commitment.
5. Work directly with Quality Manager on continuous improvement and development of quality assurance system.
6. Lead a comprehensive quality assurance system for Supplier Quality.
7. Provide engineering support in the development and maintenance of Companys quality system.
8. Participate in New Product Development to assure quality considerations are adequately covered in the design, testing and release of materials, components and products. These considerations to include, but not be limited to safety, testability, reliability, serviceability and manufacturability.
9. Investigate and respond to customer complaints with activities including analyzing causes of complaints and participating in recommendation of corrective actions.
10. Prepares inspection instructions, systems and procedures.
11. Initiate actions for the nonconforming product and material on hold systems, including placing product on electronic hold as appropriate and facilitating Material Review Boards to determine disposition of nonconforming products..
12. Interface with supplier quality representatives concerning problems with quality and assure that effective corrective action is implemented.
13. Directly interface with Quality Manager and other management representatives on quality concerns, quality trends and other associated costs.
14. Assist and/or perform activities associated with validation activities.
15. Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer and internal audits as required and develop subsequent preventive action programs as appropriate.
16. Perform product risk assessment, failure mode effects analysis (FMEA) and statistical analysis of various process parameters and/or test results of both finished products and subassembly products.
17. Assist Regulatory Affairs Department in an as needed basis.
18. Work with Quality staff and manufacturing associates in awareness training of various Quality Standards the facility is certified to.
19. Create verification and validation test plans and conduct prototype testing and analysis for reliability, MTBF, standards compliance, and product requirements compliance.
20. Evaluate internally generated Supplier Corrective Action Requests for root cause and effective corrective actions.
21. Work within the Corrective Action/Preventive Action (CAPA) program to lead CAPA teams on resolution of issues associated with the CAPA.
22. Develop sampling plans as related to in-process testing and inspection activities to appropriately monitor the manufacturing process and disposition product for compliance to both product design requirements, internal standards and external standards.
23. Work with process engineering for process improvements as related to improved quality and improved yields.
24. Process Corporate Holds.
25. In conjunction with R&D, Operations and Sales and Marketing, develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements.
26. Where applicable, implement and maintain sterilization programs for products, including pre-sterilization and post-sterilization procedures, documentation, review of results and release to inventory.
27. Approve change notices (CNs).
28. Ability to travel domestically and internationally as required. Less than 5%.
29. Must be willing to become a Certified Quality Engineer (CQE) within the first year of employment. (Company sponsored).

Requirements
Education:
Bachelor's degree from an accredited college or university required in
a technical field, Engineering preferred.

Experience:
7 years in an FDA regulated industry in a Quality Assurance function.

Preferred Skills/Qualifications:
Supervisory experience.

Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired.
 
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