Sr. Quality Engineer - Manufacturing

·     Bachelor’s degree in a technical field, preferably Mechanical Engineering or the equivalent education and applicable work experience.

·     5 plus years’ experience working as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or an FDA-regulated industry.

·     Demonstrates proficient knowledge of Quality Engineering policies, principles and best practices.

·     Proficient knowledge of quality standards (ISO 13485, FDA QMSR, ISO 14971).

·     Proficient knowledge and experience with sterilization, bacterial endotoxin testing, and cleanroom standards (ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, ISO 11737-3, AAMI ST72, ISO 14644-1)

·     Understands the use of all test and quality measurement equipment.

·     Strong proficiency of statistical techniques including sampling theory, probability, capability analysis, and SPC.

·     Previous experience generating and analyzing quality metrics.

·     Demonstrated experience using problem solving methodologies: why-why analysis, fault tree analysis, cause and effect diagram etc.

·     Ability to work independently to identify potential quality issues and propose solutions.

·     Basic understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).

·     Able to recognize non-conformances from accepted and documented practices.

·     Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

·     Skilled at promoting team cooperation and a commitment to team success.

·     Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.

·     Ability to effectively use MS Office suite (Word, Excel, Outlook) and MiniTab and other applicable software packages.

An experienced senior team member in a sustaining, manufacturing environment with ample knowledge and experience in sterilization, bacterial endotoxin testing, and cleanroom activities providing quality guidance and support for product launch, sustaining engineering, and quality system activities to ensure conformance to established specifications and risk reduction. Works independently to optimize and continuously improve internal operations to meet department, business unit and company objectives. Also provides expertise and guidance to ensure quality systems are in place across the hardware development organization that improves patient safety, product quality and business operations.

The Senior Quality Engineers at Tandem are also responsible for:

·     Serves as a Quality lead on sustaining engineering, production, and quality system activities.

·     Reviews and approves product and process changes/new designs to ensure they are developed, verified, validated and documented in accordance with regulatory requirements.

·     Assures all actions required to optimize the quality, manage the risk, and maintain the compliance of all products, planned and completed, and that the results drive quality and quality system actions.

·     Analyzes and solves quality related problems with products and processes. May

·     Provides input to IQ/OQ/PQ development for processes and equipment.

·     Manufacturing and/or test fixture qualification (requirements, protocols, execution, test report)

·     Support the non-conforming material report (NCR) process and lead monitoring and tracking for open NCRs and ensure timely closures.

·     Lead and support sterilization validation activities, including dose establishment, dose audits, requalification, and routine monitoring in compliance with ISO 11137, ISO 13485, FDA QMSR, and applicable regulatory requirements.

·     Evaluate bioburden and sterility assurance data, investigate sterilization-related nonconformances, assess the impact of manufacturing or design changes on validated sterilization processes, and ensure continued state of control through data trending, risk assessment, and supplier oversight.

·     Review and approves COs as well as provides quality input.

·     Lead and support cleanroom environmental control programs to ensure compliance with ISO 14644, applicable regulatory requirements, and internal quality standards.

·     Monitor and trend environmental monitoring data, including viable and non-viable particulate results, investigate excursions and out-of-specification conditions, assess the impact of manufacturing changes on cleanroom performance, and drive corrective and preventive actions to maintain a validated state of control.

·     Review and approve environmental monitoring protocols, reports, and cleanroom qualification documentation.

·     Support cleanroom design, validation, requalification, and contamination control strategy activities.

·     Conduct investigations and root cause analyses for environmental monitoring excursions, contamination events, and adverse trends.

·     Collaborate with Manufacturing, Facilities, Microbiology, Validation, and Regulatory Affairs to ensure ongoing cleanroom effectiveness.

·     Evaluate gowning, cleaning, disinfection, and personnel monitoring programs for compliance and effectiveness.

·     Support risk assessments and change control activities affecting controlled manufacturing environments.

·     Provides quality input to Complaint, FA, CAPA investigations Independently completes such activities in Risk Analysis, Process Capability Analysis (Cpk), DFM, Design Reviews, Gage R&R, DOEs, V&V Testing, and reliability testing activities.

·     Facilitates or participates in cross-functional or cross-divisional process improvement teams to drive product development quality excellence and cost savings initiatives.

·     Reviews and analyzes project and customer requirements and assists project teams in tailoring and using company procedures, methods, templates and tools.

·     Collects process metrics and lessons learned, reviews and evaluates processes and work products and recommends improvements as appropriate.

·     Supports and leads, internal and external audits as scheduled to build the quality system and reduce risk.

·     Confirms completion of required training plan before assuming job responsibilities.

·     Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

·     Other responsibilities as assigned.