Sr. QA Engineer

Job Description

Job Purpose

The Senior Quality Assurance Engineer works under the instruction of the Manager, Quality Engineering. This position helps to support the manufacturing of medical devices from a quality perspective.

Duties and Responsibilities

• Develop Quality System Processes in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations.

• Develop Quality Plans for the implementation of new processes or improvements to existing processes.

• Conduct internal quality audits to ensure compliance to the Quality System and regulatory requirements.

• Facilitate receiving inspection and first article inspection activities. Help establish receiving inspection requirements for materials and any needed inspection/testing procedures.

• Participate in the document change control process. Review and approve changes to engineering drawings, specifications and procedures. Assess impact on design and processes from a quality and regulatory standpoint to ensure design control and compliance with requirements.

• Facilitate equipment management activities; ensuring calibration and PM are completed in a timely manner and equipment qualification activities are completed as required.

• Control of suppliers, including supplier approval, supplier audits, supplier monitoring, and supplier corrective action.

• Facilitate material review board meetings. Initiate, investigate, disposition, and follow-up on non-conforming material reports through to closure.

• Daily line support activities in manufacturing.

• Support manufacturing with process validation activities.

• Support corrective/preventive action plans that pertain to production floor support. Work with responsible engineering personnel to perform containment actions, root cause analysis, risk analysis, develop action plans, and follow-up on implementation and effectiveness of actions taken.

• Assist with the collection and trending of key quality indicators for management review.

• Support transfer of products from development to manufacturing.

• Perform other related functions as required by quality management.

Qualifications

• Bachelor’s degree in a technical field as Engineering or Biological Science and a minimum of six-years’ experience in the field of medical device manufacturing, prior experience with medical electronics preferred;

• Ability to work with minimal direct leadership in a fast-paced environment;

• Ability to read and interpret engineering drawings, schematics and specifications;

• Self-motivated, detail-oriented, and well-organized with good communication skills, both written and oral;

• Strong analytical problem-solving ability required;

• Proficient computer skills which include the use of Microsoft WORD, EXCEL, and POWERPOINT. Prior use of an electronic QMS (e.g. NMRs, document control, etc.) and ERP system. Working knowledge of SAP, MasterControl, and AssurX preferred.

Desirable Accreditations/Knowledge

• ASQ Certifications such as Manager of Quality/Organizational Excellence, Quality Engineer, Quality Auditor, Supplier Quality Professional, etc.

• Certified ISO 13458 / MDR lead auditor.

Compensation

The anticipated range for this position is $124,500 to $138,200 at an annual base. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Working conditions

• A Senior Quality Assurance Engineer usually works in an office environment which includes laboratory and manufacturing areas. Occasional domestic travel may be required.

• A Senior Quality Assurance Engineer works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.

Physical requirements

Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs.

Full-time