Experienced Quality Engineer, or QA Engineer

In a regulated medical device manufacturing environment, manages the effective implementation of key quality systems to meet or exceed established metrics, quality objectives, regulatory requirements, and business goals. Supervises personnel responsible for incoming and final inspection as well as batch records (DHR) review. Serves as a key resource during internal and third party quality system audits.

Applies a strong knowledge of US FDA regulations and ISO 13485 requirements to the effective implementation of key operational quality system processes such as CAPA, Supplier Corrective Actions, Complaint Handling, NC Material Tracking and Disposition, DHR Review and Records Management, Work Environment, and Contamination Control.

Monitors key quality system metrics and interacts with owners of open items to ensure the timely completion of quality system activities according to the requirements of QMS procedures.

Provides training and direction related to quality systems to other associates.

Owns and manages change and improvement projects and corrective action activities in their area of responsibility.

Acts as a resource to lead or guide improvement and corrective action teams throughout the organization.

Tabulates, analyzes, and reports quality system metrics used in operational management and quality system processes such as Internal Audit and Management Review.

Manages records retention activities and directs the disposition of records according the approved procedures.

Develops curriculum and provides a portion of introductory training in Good Manufacturing Practices to new employees during orientation. Manages test development and administration of the annual GMP retraining and testing activities.

Serves as one of the primary resources during internal and third party audits either by directly interfacing with auditors or regulators or organizing “back room” activities.

Serves as the primary reviewer of outgoing Certificates of Compliance and associated data.

May serve as backup reviewer for DHR reviews.

Required Skills/Abilities: Bachelor’s degree in engineering or equivalent discipline or equivalent work experience Minimum 5 years in a manufacturing environment preferred (work or school) Strong knowledge of relevant software, quality assurance methods, tools and quality manufacturing processes Math skills Communication skills Knowledge of the organization’s product Attention to detail Analysis, critical thinking and problem-solving skills Interpersonal skills Ability to handle stress

Preferred Experiences: Medical Device industry experience. ASQ Certified Quality Engineer, Six Sigma Black Belt. Risk Management Principles. Demonstrated knowledge of compliance to ISO 13485 and FDA 21CFR 820.

401(k) 401(k) matching/ Dental insurance/ Flexible spending account /Health insurance/ Life insurance /Paid time off /Retirement plan /Tuition reimbursement/ Vision insurance