Quality Engineer 3
ESSENTIAL DUTIES AND RESPONSIBILITIES The position serves as a technical resource helping to insure that the medical operations function within regulatory and relevant standards requirements, customer requirements are met and that the final product meets all customer requirements. Responsibilities Must be able to interpret and apply regulations and standards to the quality management system (QMS) and to the production environment. Communicates with customers, sales and global quality regarding current products, new products, validations, corrective action, and projects as needed. Serves as a technical resource for regulations that apply to the operations and customers. Writes validation protocols and coordinates quality and validation activities. Conducts First Article Inspections. Participates in customer, FDA, ISO audits and Internal Audits. Completes CAPA and Root Cause Investigations. Maintains records, metrics, and non-conformance database. Writes work instructions. Reviews and approves process and material deviations. Supports QE Team members, completes all required training programs, participates in improvement projects. Performs other duties as assigned by the Quality Manager Required Skills RRD is an EEO/AA including Vets and Disabled Employer Required Skills The duties and responsibilities described above are the essential functions of the job. The qualifications below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor degree in discipline related to functional work or role with 5-7 years of relevant work experience OR demonstrated ability to meet the job requirements through a comparable number of years of applicable work experience. Candidate must be competent in spoken and written English. Must have the ability to communicate and work well with others at all levels of the organization, with customers and with external auditors effectively and professionally. Must be able to influence others at all levels of the organization. Must be able to work on personal initiative, have the flexibility to manage change, and prioritize workload. Must be confident in their ability to make decisions balancing business requirements with quality requirements and the associated risks. Must possess excellent computer skills, i.e.:
Microsoft Office including Excel, Word and Power Point. JDEdwards or an ERP system experiences a plus Six Sigma, ASQ, CQE or CQA, and quality auditing experience preferred
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Microsoft Office including Excel, Word and Power Point. JDEdwards or an ERP system experiences a plus Six Sigma, ASQ, CQE or CQA, and quality auditing experience preferred
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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