Sr. QA Analyst | Maryland Heights, MO

Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.

Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.

with other departments regarding Receiving and Quality Control requirements. Record, Disposition and Investigate NCRs and RMAs in a timely manner. Comply with applicable Quality Management System requirements; including Quality Policy, Quality Manual, QMS Procedures, Work Instructions, Forms, Recordkeeping, etc.

Support and fully participate in QMS related activities Participate in cross-training to improve ongoing efficiency and business continuity. Maintain clean and orderly work environment. Participate in end-of-year inventory process and assist in resolution of inventory discrepancies. Perform other tasks as deemed necessary by Supervisor. Qualifications High School diploma or equivalent

education Can effectively execute the above listed duties and responsibilities without limitations Follows written and verbal directions with limited oversight Effectively communicates, reads and writes in English language Able to multi-task with frequent interruptions in a fast-paced environment Can perform and cross-train associates in detail-oriented QC inspection techniques Able to interpret QC technical drawings and diagrams Able to carefully handle fragile items and inspect under microscopic magnification Willingness to work on interdepartmental assignments as required Working conditions The job is performed at our facilities in a climate controlled non-smoking environment.

It requires

a person to work day shift and overtime as peak workload may require.

Physical requirements The job requires standing and sitting for extended lengths of time and the ability to lift and manage packages and products weighing up to 30 lbs. Direct reports None.

Management System (QMS) from ISO9001:2015 to ISO13485:2016 at 3 locations, including one in Costa Rica. This is a critical project for us, as it will enable us to streamline our processes and ensure compliance with the latest industry standards. As the Quality Manager, you will play a key role in driving this initiative forward, and you will have the opportunity to work with a talented team of professionals who are passionate about making a difference in the medical device industry.

This position offers an excellent opportunity for an experienced candidate to advance their career and make a significant impact on the success of our organization. Duties and responsibilities Lead the organization

to establish and continuously improve the Quality Management System; including certification to the current ISO 9001:2015 Quality Management Systems Requirements across multiple sites.

Upgrade the organization to ISO 13485:2016 across multiple sites. Oversee effective deployment of human resources throughout the department. Serve as the ISO Management Representative for the EDC Management Team, including administration of periodic Management Reviews; review and maintenance of the Quality Policy, Quality Manual, QMS Plan and Quality Objectives; and response to external QMS related inquiries. Provide quality management support for all QMS processes, with specific oversight and implementation

responsibility for Nonconformities, Corrective Actions, Document Control, Internal Auditing, and QC Inspection of Image Bundles and Small Diameter Subassemblies.

Performs root cause analysis and works with Production Support to prevent manufacturing defects. Provide QMS Communication and Awareness training throughout the organization; providing daily direction and guidance as needed to ensure accurate and consistent application of QMS processes. Coordinate external audit activities and serve as primary contact for certification and surveillance audits, 3rd party and customer audits. Manage customer complaints, establish trending, implement corrective actions and respond appropriately to all investigation requests.

Reviews daily on-the-floor quality related issues with other applicable department management to determine need for corrective actions. Reviews incoming returned product from customers as either nonconforming product or returns for restock. Works directly with customers on review of nonconforming product to include issuance and management of corrective actions (8D's), as required, and visits to the customer facilities to report on actions taken to address quality concerns. Works with suppliers on incoming product quality issues to include issuance of supplier corrective actions, as necessary.

Works with R&D to ensure all product specifications are developed for new products and maintained throughout batching process and production for all products. Support needs of external customers as needed. Qualifications Minimum of bachelor's degree in relevant business or scientific discipline, or a bachelor's degree and a minimum of four years of related experience Prior leadership experience and maintaining an ISO 9001 certified or comparable QMS. Working knowledge of 6 Sigma and Lean Methodology Working knowledge of process validations Possess strong communication and interpersonal skills to address and resolve issues in a positive manner.

Excellent working knowledge of MS Office products, document control systems and quality management tools. Ability to work without being distracted by internal or external influences to effectively execute the above listed duties and responsibilities. Working conditions The job is performed at our facility at 14062 Riverport Dr. in a climate controlled non-smoking environment. It requires a person to work a standard day consistent with exempt employee expectations, where occasional extra effort may be needed to support the organization's needs.

The position may also require occasional overnight travel.