Quality Assurance Specialist - HC

Description

• Reviewing qualifications of new vendors and maintaining vendor log and documentation
• Documenting and executing the disposition of returned product
• Facilitating continuous improvement projects and acting as support to meeting various company goals
• Looks for ways to improve and promote quality across multiple departments and functions
• Coordinating and documenting vendor returns and product reworks
• Assisting with investigating and dispositioning customer returns
• Observes quality, safety, and security policies and procedures
• Ensuring product is dispositioned and nonconformance reports are closed in a timely manner
• Supporting various Quality processes such as corrective/preventive actions and internal audits
• Working with Engineering on ad-hoc projects such as documentation and drawing reviews, product testing, temporary deviations, and implementing change orders
• Conducting vendor evaluations including, as needed, vendor audits and corrective actions
• Receiving and sorting customer returned product
• Assessing processes to identify potential improvements to quality and efficiency
• Managing nonconforming product process
• Conducting process and software validations as required
• Conducting regular Production audits to confirm quality checks are being performed as specified
• Takes responsibility for own actions and edits work for accuracy
• Commits to communicating and coordinating scheduling needs to ensure work is covered
• Inspecting returned product to confirm it meets requirements for return to inventory
• Overseeing vendor approval, evaluation, and monitoring to ensure product conformity
• Releasing product and acting as work coverage for Incoming and Final Inspectors as needed
• Reviewing work instructions to ensure they are accurate and being followed
• Overseeing Preventative Maintenance audits to ensure all required checks are being conducted and documented per our procedures
• Working with Operations to identify process failures and/or potential improvements

Requirements

• Ability and desire to work closely with others as an effective team player
• Forklift operator certification
• Excellent time management skills and the ability to balance multiple responsibilities
• Ability to read, analyze and interpret documents such as safety rules, operating and maintenance instructions, dimensional drawings/specifications and procedural manuals. Ability to write reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
• Infrequent (less than 5% of the time). Valid passport and willingness to travel to other company sites or supplier locations as needed to acquire product knowledge or conduct onsite audits is preferred.
• High School Diploma or general education degree (GED)
• Educational or professional background in quality, science, or engineering:
• Comfortable with and capable of communicating successfully with internal and external customers
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook is required. Proficiency in ERP system such as Microsoft Dynamics AX12 and electronic Quality Management System such as Qualio is preferred.
• Mechanically inclined, preferably with experience using electronic and pneumatic equipment
• High level of initiative to complete tasks accurately, thoroughly, and in a timely manner
• ISO 13485 Lead Auditor certification
• Exceptional communication skills and the ability to both write and speak clearly and effectively
• Knowledge of quality system requirements, such as ISO, FDA, etc.
• Follows instructions and responds positively to management direction
• The employee may occasionally stand, walk, stoop, kneel or crouch during shift. Employee will be required to regularly sit, use hand to finger, handle, feel and reach with hands and arms. Employee must be able to occasionally lift and or move up to 50 lbs.
• Already obtained or willing to pursue the following certifications is preferred:
• Bachelor of Science degree (B.S.) from a four-year college or university OR
• Associate or Technical degree and 1 to 3 years of professional Quality Assurance experience
• Experience in the operation of inspections equipment (micrometers, calipers, etc.)

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance