Share Email Opening Apply Now Title Quality Engineer - Sustaining Products  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description SUMMARY: The Quality Engineer is responsible for supporting process improvements, risk management activities, supplier management, complaint process, design control activities, audits and environmental monitoring as it relates to sustaining products. The Quality Engineer participates in review and approval of Quality System documents, resolves quality issues and ensure quality control of products and processes, in compliance with all applicable company policies and procedures. DUTIES AND RESPONSIBILITIES: Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner. Meets commitments on time with accuracy and attention to detail. Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents. Maintains a working knowledge of applicable statistical techniques for validation and process capability/performance purposes. Quality Representative for Risk Management Activities for existing products. Provide interpretive assistance, to all departments, regarding quality documents. Support training on Manufacturing and Quality System documents. Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review). Responsible for the complaint process including initiating an investigation, interfacing with customers to gather necessary details and close out investigations. Support, investigate, determine root cause and respond to customer complaints and customer issued SCARs. Interface with Engineering to drive continual improvement on existing manufacturing processes. Develop validation and/or verification protocols for changes related to process improvements; execute validations/verifications and report on the conclusions to support process improvements. Quality Representative for Design Control Activities for existing product lines. Release documents via the change control process as necessary. Train others where required. Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols), as related to existing products. Daily oversight of the Prepare quality related deliverables in a timely manner. Prepare and execute Engineering studies as needed. Participate in CAPA root cause investigation and actions implementation. Implement ongoing quality improvement processes working with cross functional teams. Support customer and regulatory audits. Acts as a consultant for areas related to his/her expertise. Performs other related duties as assigned by management. May participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified. Quality Representative for Contract Review activities on existing products. Provides support as the primary Quality representative for Notices of Change (NOCs), Notices of Activity (NOAs), and Nonconforming Material Reports (NCRs) related to existing products. Acts as a backup to the Quality Engineer - New Product Development (NPD).   Position Requirements QUALIFICATIONS: A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge. Basic knowledge of ISO 13485:2016 and FDA QSR. Strong root-cause investigator and problem solver within a manufacturing environment. Mechanical aptitude with manufacturing experience. Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos. Experienced in statistical analysis. Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form. Well versed in data management and graphical presentation of data. Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required. Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization. COMPANY COMPETENCIES: Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. SUPERVISORY RESPONSIBILITIES: This job has no supervisory responsibilities. JOB COMPETENCIES: Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. Validation / Verification – Has a clear understanding of how to design and execute validation and verification activities as they pertain to new product development, process improvements and/or changes. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Utilizes data analysis to justify process changes. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. PHYSICAL DEMANDS AND WORK ENVIORNMENT: Occasionally required to stand Occasionally required to walk Frequently required to sit Occasionally required to climb, balance, bend, stoop, kneel or crawl Frequently required to talk or hear Occasionally work near moving mechanical parts   Location AdamSpence   About the Organization Based in Alpharetta, Georgia with multiple plants across the United States, Mexico, Costa Rica, Ireland and Malaysia, Spectrum Plastics Group is a North American leader in the development and manufacture of specialty medical plastic products. Only Spectrum Plastics Group has the product breadth, expertise and global reach to deliver critical medical plastics at scale. We deliver operational excellence, innovative solutions and a high level of execution resulting in what our customers value most: precision, performance and repeatability. Spectrum Plastics Group offers a full range of custom design, engineering and fabrication services, as well as meets the requirements of ISO 9001, ISO 13485, FDA, operating multiple Class 7 & Class 8 clean rooms. When medical plastics are critical, the industry trusts us. Specialties: High performance extrusion Tight tolerance extrusion Extrusion Precision injection-molding Micro-molding Medical tubing PVC tubing Silicone Packaging Finished Devices/Assembly Contract manufacturing Clean room Thermoplastic tubing extrusion Medical device Medical plastics Medical components Microbore extrusion Bioabsorbables Catheters   This position is currently accepting applications. Apply Now Follow us See who works here:

 

AppOne.comTM   copyrightŠ1999-2021 HR Services, Inc. Click here for technical assistance.