The Quality Engineer New Product Development (NPD) is responsible for supporting all quality engineering activities to support the new product life cycle, from concept through commercialization and sustaining changes, as part of a cross-functional development team. Serves as the key resource for ensuring compliance to ISO, MDD and QSR requirements for Medical Devices. Takes the lead with quality initiatives with inter-organizational impact following QSR, ConMed Policies and standards. Works under direction from Quality Management.
Duties and Responsibilities:
Quality Engineer supports and provides direction to product development teams as to the required quality deliverables ensuring that product design and processes meet customer expectations, regulatory requirements, appropriate voluntary standards and all corporate and divisional requirements with respect to safety and efficacy.
Leads and provide support on risk management activities for new and sustaining engineering projects. Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
Review, assess and approve product design milestones, DHF and deliverables to ensure compliance throughout product development cycle.
Supports and provides guidance to Manufacturing Engineers during the process development and validation activities. Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
Support post market activities such as complaint investigation, complaint trending. Performs Predicate Device reviews and surveillance reports. Able to perform data mining, trend reports (Oracle, Report Builder, Crystal and DMAIC).
Provides guidance about Six Sigma principles (Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis)
Provides support in change management tasks, process improvement efforts and supplier changes.
Initiates and leads investigations as part of the CAPA Process for product/process non-conformances, customer complaints, and internal audits in concert with other departments (i.e. R&D, Manufacturing, Service, Purchasing, etc.).
Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
3 years plus experience depending on the level of education received. Experience or advance training in Quality System requirements, statistical methods, problem analysis and resolution, design control, design of experiments, production and process controls, corrective and preventive action preferred.
B.S. degree in Electrical or Mechanical Engineering and 3+ years of medical device experience (or equivalent work experience), M.S. and 1+ years of medical device experience. Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable. Design for Six Sigma training is desired along with knowledge of statistical methodologies.
Knowledge of design controls and 21CFR820, ISO 13485, ISO 14971 and applicable medical device regulations. Must be able to interpret and apply Quality Systems Regulations and ISO quality requirements and stay abreast of new industry standards and concepts. Excellent communication, problem solving, organizational and interpersonal skills are required. Must be capable to plan schedules and to manage multiple projects simultaneously.
Ideal candidate would have experience with electro-mechanical design, software validation, and related US and international standards.
Additional Salary Information: CONMED offers competitive salaries and a robust benefits plan including: health, dental, vision, short & long term disability, tuition reimbursement, 401K match dollar for dollar up to 7% and more!
Internal Number: 5374
CONMED Corporation is a progressive, global medical device company. Through thoughtful leadership, innovation and team work, we are changing the future of medicine. Our 3,500 employees worldwide make meaningful contributions, positively impact the business, and advance in their careers as our company and product portfolio grows.
We are a leader in Orthopedics, General Surgery, Gynecology, Gastroenterology, Pulmonology, and Anesthesiology and our employees enjoy challenging and diverse job opportunities across these varied specializations. We are headquartered in upstate New York with additional domestic facilities in FL, CA, MA, NJ, CO, and GA. We have an international presence in more than 20 locations throughout Europe, Australia, Latin America, Asia, North America, and the Middle East.
CONMED is an Equal Opportunity Employer & an Affirmative Action Employer