Quality Engineer II

Position:  Quality Engineer II

DUTIES: Responsible for providing quality engineering support for Operations to ensure that the Quality Systems requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide QMS support, engage in continuous improvement initiatives with cross functional teams, conduct validation and process verification, and participate in customer facing activities. Specific job duties include: (1) Supporting regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality; (2) Monitoring the manufacturing of assigned products and assuring compliance with DMR; providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained; and implementing various product and process improvement methodologies; (3) Reviewing Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specification, FMEAs, and Control Plans for adequacy and correctness of changes; (4) Maintaining risk analysis; (5) Completing protocols and reports for test method validation; (6) Interfacing with Manufacturing Engineers to review processes for new and existing products; coordinating process validations and capability studies; and recommending process monitoring devices; (7) Developing various inspection techniques and procedures to ensure product integrity to design specifications; (8) Ensuring that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence; (9) Leading customer complaint investigations and analysis to identify and resolve sporadic and chronic quality issues ensuring production of safe and effective medical devices; (10) Executing plant CAPA activities, including analyzing data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes; (11)  Executing capability studies and applying statistical quality control which includes Cpk, DOE, and Hypotheses Testing; (12) Coordinating the preparation of Quality Plans, including inspection, testing, and gauge requirements for new product introductions; (13) Initiating writing necessary documents needed for product launch (e.g., MVP Master Validation Plan and Component Risk Protocol), TMVs (Test Method Validations), and component and in-process device inspections; (14) Performing machine, process capability, and performance studies; and recommending and implementing changes and upgrades to systems, procedures, and processes to improve product quality; (15) Assessing compliance with applicable regulations within the manufacturing processes and recommending improvements to ensure that safe and effective products are produced; and (16) Training Quality Assurance Inspectors and manufacturing personnel so they understand product specifications, new product audits, procedures, environmental controls.

MINIMUM REQUIREMENTS: This position requires a Bachelor’s degree or equivalent in Industrial Engineering or a related field and 5 years related (progressive, post-baccalaureate) engineering experience in the medical device, healthcare or pharmaceutical industry. Must also have 12 months of experience with each of the following: (1) Regulatory standards including FDA Quality Systems Regulations, ISO13485, and ISO14971 risk management methodologies; (2) Utilizing statistical analysis and validation techniques including Statistical Process Control, Capability Analysis, Hypothesis testing, and Acceptance sampling; (3) Interpreting technical engineering drawings and specifications, and working with FMEAs and Control Plans; (4) Leading end-to-end test method validation activities and writing comprehensive validation documents; (5) Conducting corrective and preventive actions (CAPA) in manufacturing using formal problem-solving tools and comprehensive documentation to address root causes and prevent recurrence; and (6) Developing and implementing inspection procedures. Employer will accept experience gained concurrently. Salary: $106,683.00/year. Full-time, position located in Grand Rapids, MI. Please apply online at viantmedical.com/careers/us-jobs/.

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