Quality Engineer II

Teleflex•Olive Branch, MS

About The Position

The Quality Engineer will support Quality and Operations, interact with cross-functional team members and internal customers, and provide support for Engineering, Quality Systems, projects, and Process Engineering. Activities include nonconformance and CAPA coordination and processing; service complaint investigations; process and product validations; customer notification-of-change evaluations; internal and external auditing; audit support; statistical analysis; quality and continuous-improvement projects; and ensuring compliance with applicable Teleflex global and local procedures and policies. The role independently leads quality activities involving nonconformance and CAPA processing, supplier quality, complaint investigations, validation, audits, documentation control, statistical methods, testing, and continuous improvement. It also provides project management support and performs additional Quality Assurance tasks as assigned by the QA Manager. The position requires 10% travel.

Requirements

Bachelor's degree in engineering.
At least 3 years of Quality Assurance experience.
Knowledge of Quality System Requirements, including ISO 13485 and CFR 820.
Excellent communication and presentation skills.
Experience with Quality Assurance in a medical-device environment, including 21 CFR 820, ISO 13485, and risk management under ISO 14971, is highly preferred.
Experience with corrective action, manufacturing, and design-control concepts is desired.
Computer literacy, including statistical software and analysis, report-generation tools, and presentation software.
Proficiency with Microsoft Word, Excel, and PowerPoint.
Problem-solving skills and experience with root-cause analysis tools such as 6M, cause-and-effect, and 5 Whys.
Good listening, verbal, and written communication skills.
Excellent interpersonal skills and demonstrated ability to work in a team environment.
Ability to prioritize work, adapt to shifting priorities, solve problems and conflicts, and proactively effect change.
Ability to work independently with limited supervision.

Nice To Haves

Project-management experience.
Experience with SAP applications.
Manufacturing or distribution experience.
Quality certification, such as CQE, CRE, CQM, or Six Sigma.
Relevant experience in the medical-device, pharmaceutical, or another FDA-regulated industry.

Responsibilities

Independently lead nonconformance and CAPA activities, including Material Review Board coordination, inspection methods, containment, correction, closure, and trend analysis.
Serve as CAPA Champion as needed by coaching and supporting CAPA Owners, monitoring due dates, running CRB meetings, tracking and escalating actions, archiving records, and training new owners; serve as CAPA Owner or Phase Owner when assigned.
Investigate and facilitate service complaints, including confirmation and corrective actions, act as the primary customer contact for complaint communications, and drive improvement based on trends.
Perform supplier quality activities, including onboarding, evaluation, performance monitoring, and supplier corrective actions; identify and resolve supplier-system nonconformances.
Guide and review process-validation protocol development, implementation, and report acceptance.
Lead and participate in quality and cost-improvement projects for product or process improvements.
Maintain compliance with Quality System Regulations and ISO 13485 standards; support FDA and ISO inspections and registration and identify relevant procedures and records for audit requests.
Perform documentation control activities, including product specification reviews; prepare procedures, work instructions, and training materials; and conduct training on QMS and Quality Assurance activities.
Manage and lead continuous-improvement projects and provide project-management support as needed.
Develop standard methods for inspection, testing, and evaluation using knowledge of related engineering fields.
Apply statistical techniques to recommend sampling plans and sample sizes, support inspection processes such as AQL, and support statistical product testing, verifications, and validations.
Use statistical techniques to identify trends in product and process capabilities and quality-system metrics.
Apply knowledge of process controls, inspection steps, disposition requirements, critical-to-quality inputs and outputs, critical-to-function characteristics, and Statistical Process Control.
Use measurement methods, tooling, and equipment, including performing complex measurement tasks such as tensile and burst testing.
Establish testing methods based on applicable standards; identify measurement-process nonconformities and participate in their resolution.
Conduct measurement-system analysis or repeatability and reproducibility studies when required for test-method validation.
Use problem-solving tools and lean principles.
Perform additional Quality Assurance tasks as assigned by the QA Manager.