- Follows all Quality Management System requirements and company procedures ensuring regulatory requirements are met, encourages all associates to do the same
- Meets commitments on time with accuracy and attention to detail
- Maintains current knowledge of applicable medical device regulations (FDA QSR, ISO 13485, ISO14971) and related standards or guidance documents.
- Based on assignment, the engineer will support either or both of the following teams:
- Development-Customer Focused Team: Assures the Customer Focused Team (CFT) meets or exceeds customer, company, and regulatory requirements by working as the CFT quality representative in support of the development, and qualification of processes to ensure product manufacturability. Works directly with customers and process development engineers and project managers to translate customer requirements and product specifications into process development deliverables and process specifications. Develops and validates test methods as required to ensure measurement systems provide valid data for assuring requirements and specifications are satisfied. Creates standard work for new product development. Provides on-the-floor quality engineering support for new process development during developmental manufacturing runs.
- Production-Production Focused Team: Assures the Production Focused Team (PFT) meets or exceeds customer, company, and regulatory requirements by working as the PFT quality representative in support of manufacturing and process improvement. Provides on-the-floor quality support, as needed, to resolve production issues and to ensure proper implementation and use of process controls. Investigates and supports resolution of customer complaints, process or product nonconformities, and supplier quality issues. Identifies and implements opportunities for process improvement, new or revised process controls, improvements in productivity and costs. Maintains standard work for existing product processes. Supports customer or company-initiated changes to equipment, manufacturing location, processes, materials or product specifications.
- As required, works with Development, Production, Quality, Sales, and Customers to create, document and execute/implement:
- Risk assessments (PFMEAs)
- Quality Plans and Control Plans
- Production and inspection procedures including identifying and establishing incoming inspection requirements
- Test method development and validation, gage R&R
- Equipment installation qualification (equipment IQ/OQ) protocols and reports
- Process characterization, risk-based process operational and performance qualification (OQ/PQ) protocols and reports
- Establishing statistical process controls
- Communicates with customers and within the organization to ensure potential nonconformances and potential product issues are identified and documented according to company procedures (i.e. nonconforming material, material review board, customer complaints, corrective actions, CAPA processes, customer notice of change, and supplier notice of change)
- Provides technical expertise and uses industry standard Root Cause Analysis methods for product and process issues to ensure identification of assignable and root causes, identification and implementation of required containment and immediate corrections and long-term corrective actions
- Provides expertise in risk-based sample size determination, and statistical analysis of data. Presents data and data analyses accurately and audience appropriate in presentations and/or reports
- Supports continuous improvement (CI) and Lean initiatives, may lead or sponsor CI and Lean initiatives
- Leads risk assessment activities for both new and modified process development projects, as well as process and equipment changes. Reviews and updates risk assessment documentation for new or altered risks based on nonconformities, customer complaints, change requests, and other Quality System inputs
- Supports and provides technical expertise to many Quality processes including supplier management, Material Review Board, Change Control, Calibration, Preventive Maintenance, Equipment controls, Environmental controls, and other processes where out of specification, unexpected excursions or corrections are encountered
- Acts as a subject matter expert for external audits as needed, may participate as part of the internal or supplier auditing team
- Performs other related duties or special projects as assigned by management
- Bachelor's degree in science, engineering or technical field for Sr. QE or higher.
- Experience in medical device or related fields highly desired, with direct experience related to job responsibilities for QE1 level or higher
- Understanding of statistical techniques, data management, investigation techniques, and technical writing
- Excellent verbal and written communication skills, both internally and with customers in a professional manner
- Critical thinking skills with desire to continue learning
- Strong team player with project management skills for QE2 level and higher
- Ideal Team Player (Humble, Hungry, and Aware) preferred.
- Well-developed written and verbal communication skills. Ability to present information to all levels within the organization, regulators, and customers
- Results oriented, self-starter, who can work independently
- Strong attention to detail
- Organized and able to maintain organized records
- Able to accommodate, track and deliver on multiple projects simultaneously
- Proficient with Microsoft Office software, and familiar with ERP and statistical software (EPICOR, Minitab or similar)
- Able to create graphs and tabulate data using the appropriate software for the presentation of data
- Ability to work in office setting.
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Description
Job DescriptionTitle: Senior Quality Engineer
Reports to: Senior Quality Engineer Manager
Summary: Quality Engineer will drive a Culture of Quality and Continuous Improvement within the company by promoting adherence to the Quality System requirements across all departments. Quality Engineer is responsible for ensuring customer, company, and regulatory requirements are met or exceeded while simultaneously meeting company cost and productivity goals by supporting the development, improvement and qualification of manufacturing and inspection processes. Quality Engineer is also responsible for applying risk-based established industry standard scientific and engineering problem-solving methods to identify, document, communicate, prioritize, and resolve quality issues (e.g. nonconformances, material review board, customer complaints, and corrective actions). Quality Engineer is responsible for creation and documentation of process risk assessments, quality plans and control plans. Quality Engineer also provides cross-functional quality technical support to the owners of key support functions including but not limited to, supplier management, change management, environmental control, equipment/tooling control including calibration and preventive maintenance. The Quality Engineer is the key resource for the use of statistical techniques and validation activities (e.g. statistical process control, risk-based sampling, Gage R&R, Test Method Validation (TMV), DOE, process characterization, validation, and capability studies). Quality Engineer may occasionally provide support to the Quality System Compliance function by providing subject matter expertise during internal, supplier and external audits.
Quality Engineering is stratified into different skill levels of advancement:
A subject matter expert in Quality Engineering with skilled expertise in multiple Quality Engineering methodologies. Works independently providing support and mentorship or supervision to others in the department as well as providing leadership within the organization. Minimal oversight is required by this position with employee showing a self-directed work style and leadership within and outside the Quality team. Demonstrated risk-based decision-making skills including being able to navigate ambiguity. Strong technical writing and critical thinking skills. Understands risk in the application of controls and mitigations, to ensure business objectives are met. Actively owns and improves processes and customer satisfaction (delivery) metrics.
Duties/Responsibilities include but are not limited to:
To view our Equal Employment Opportunity and Affirmative Action Statement, .
