Quality Associate

About the job

The Quality Associate is responsible for managing Inspections of products and assisting engineers in developing and maintaining test methodologies and providing quality control technical support within new product development, manufacturing, and quality systems.

Major duties and responsibilities:

• This position is responsible for a combination of functions within Quality including Lot history record review and release, inspection/testing (equipment management, inspection/testing, quarantine control and documentation.
• Maintain all Incoming Quality Assurance (IQA) records, Quality Assurance (QA) release logs, Equipment files, and databases e.g. Inspection records NCMR, etc
• Conduct Lot History Records (LHR) / Product Release: Review and release LHRs and Product Release documentation to ensure compliance with Quality System requirements and notify management regarding discrepancies or irregularities.
• Monitor and report trending data monthly quality reports.
• Receiving and Inspection: Act as a backup for receiving activities regarding materials with Purchase Orders per released procedures, ensuring correct items, quantity, and documents are provided by suppliers.
• Inspection/Testing: Perform inspection/testing activities pertaining to manufacturing in process, Incoming (IQA), First Article Inspections (FAI), final packaging, and final lot release testing.
• Maintain traceability, identification, documentation, and applicable records to provide evidence of product and processes meeting requirements.
• Manage Equipment Log and Perform Calibration/PM of equipment’s, of minimal to moderate complexity including new and current equipment that requires calibration/preventative maintenance.
• Responsible for monitoring, maintaining and optimizing performance of the equipment management SOP and related documents, including maintaining records ensuring documentation follows SOP and quality requirements.
• Identify areas of improvement and participate in continuous improvement projects.
• Generate detailed and accurate inspection and testing reports in accordance with Current Good Documentation Practices (GDP) and company Quality Management System requirements.
• Document Control: Act as backup for Document Control Specialist
• Process document change orders.
• Support the Nonconforming process by reporting and verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product.
• Support CAPA process by assisting in the investigation and implementation of corrective actions as needed.
• Work with Engineering staff to resolve issues in a timely and effective manner.
• Perform activities in a variety of cross-functional areas including production planning, quality management, equipment management and new process implementation Inform responsible personnel of concerns involving product quality.
• Safety: Performs job functions in a safe and effective manner
• Adhere to the safety procedures of the company.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable regulatory requirements.
• Other Duties: As assigned.

Education/Experience requirements:

• Associate degree required or equivalent combination of education, training and experience in technical discipline.
• Minimum of 5 years in medical device or similar product design and/or manufacturing required.
• Minimum of 3 years performing QA inspections/testing activities pertaining to IQA, in process, lot release testing required.

Other qualifications:

• Good Understanding of Regulations and Good Manufacturing Practices
• Working knowledge of engineering terminology and basic computer proficiency and familiar with software’s such as Word, Excel, Project, Solidworks/CAD, Statistical software.
• Ability to multitask within a dynamic start-up environment
• Detail oriented in performance and documentation
• Able to communicate effectively and work within a team environment.

Physical demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to stand, walk and sit for extended periods of time.  Occasionally the employee will be required to lift or move at least 50 pounds.  Spending extended periods of time under a microscope.  Travel may be expected upwards to 25% of time.

To Apply:

Interested candidates should submit their resume to careers@shapemem.com with the job title as the subject.
Resumes from recruiters will not be accepted.