Hill-Rom Quality Assurance Engineer in St. Paul, Minnesota
The QA Engineer, part of the QA team located in St. Paul, MN, will work to provide the necessary data to make effective quality and business decisions, and will implement sound, data-driven quality and business solutions that emphasize quality system compliance.
The primary accountability of the QA Engineer is to collect, analyze and track key data across the St. Paul site related to entity quality and to monitor and to monitor key performance indicators by interfacing with key partners across the corporation.
The incumbent will manage a dashboard of Key Performance Indicators for site management that provides consistent and timely analysis and publication of indicator metrics.
The QA Engineer will perform or support the performance of trend analysis to identify and mitigate quality risks. The incumbent will promote a culture of Quality Matters across the site and the corporation.
Essential Duties and Responsibilities:
Support and perform investigations to determine the root causes of product or process failures. Facilitate and complete investigations when manufacturing or design challenges are encountered.
Lead and support CAPA-related activities including root cause investigations, action plan development and effectiveness verifications as required.
Monitor key product and process related metrics. Identify opportunities for improving process.
Perform trend analysis on key performance indicators. Publish trends as required in local and global scorecards. Support or lead the collection of key data for the assembly of site Management Reviews and Product Performance Reviews.
Monitor the post-market performance of products. Assemble complaint trend reports and monitor complaints for possible corrective action.
Implement the supplier quality process. Identify, qualify, develop and manage performance of suppliers.
Production support. Attend Material Review Board and document whether further investigation is required for products identified as nonconforming.
Support the transfer of new products into the St. Paul facility and the qualification and validation of new production processes as appropriate.
Support manufacturing operations, packaging, kitting, shipping, late-point configuration, servicing and any other quality related activities in the St. Paul site.
Interact with R and D and operations groups in Singapore to ensure appropriate cross-functional support is provided.
Author and review Nonconformance Evaluation reports for issues identified in operations, post-market, quality systems and other areas to ensure that site listening systems remain effective.
Write quality system procedures to accurately reflect work performed in the facility, and ensure those processes are efficient and reflect compliance to all appropriate regulatory requirements.
Lead and/or support any required Quality Improvement activities in the St. Paul site, ensuring that an effective program of improvement is maintained.
Other duties as assigned.
Required Education, Experience and Qualifications:
BS in Engineering or closely related Bachelor’s degree required.
At least 2 years of Quality/Regulatory experience is required.
Experience in the Medical Device industry is required.
Experience with the creation of key indicators and the ability to influence business processes using KPIs and metrics is required.
Strong leadership skills, strong interpersonal skills, and the ability to deal effectively with system users are required.
Knowledge of Quality Systems and Process Improvement is preferred.
CQA, CQE or RAC preferred.
Experience in New Product Development/Design Controls is desirable.
Experience with 510(K) preparation and submission is desirable.
Primary Location: United States-Minnesota-St. Paul
Posting Entity Hillrom
Req ID: 19123399