Senior Quality Engineer (R&D Design Assurance)
Click the Facebook, Google+ or LinkedIn icons to share this job with your friends or contacts. Click the Twitter icon to tweet this job to your followers. Click the link button to view the URL of the job, which then can be copied and pasted into an e-mail or other document.
Vernon Hills, IL 60061
- Job Description Summary
- Job Description
The primary purpose of this position is to ensure that product designs and the processes for manufacturing them meet all BD and regulatory requirements with respect to safety and efficacy\. Incumbent is expected to be an active team member and cross\-functional collaborator on new product development and change control project teams for medical devices; be an active team member for investigating post\-production trends and/or other quality issues\. The individual is responsible for supporting the Unit Quality/Design Assurance function within the Pleural and Peritoneal Access \(PPA\) platform\. The individual maintains communication with the Unit Quality Manager for assistance in resolving major quality initiatives/projects and executing design, development, and design transfer initiatives\.
The individual must be able to work under general direction to independently determine and develop approach to solutions\. The individual must be able to work closely with senior business unit and manufacturing plant management as well as other functions \(e\.g\. Regulatory Affairs, Research and Development, Sustaining Engineering, Manufacturing Quality, Operations, Sterility Assurance, Packaging, Sales, Marketing, Finance etc\.\)\. The individual interacts with:
+ Research and Development and Product Engineering regarding quality planning and project execution that will have significant impact on the business\. \(i\.e\. new product design and development, design change, change management\)
+ Regulatory Affairs and Quality Systems regarding new regulations and standards as they apply to regulatory submissions and managing certain quality procedures\.
+ Designated Complaint Handling Unit \(DCHU\) on complaint handling/resolution, situational analysis, and risk management pre\-/post\- product launch
+ Packaging Technology Center on new product packaging projects
+ Sterility Assurance on sterilization process \(re\)validations, standards and new product design applicability to the proper sterilization cycle and/or modality
+ Business Unit Management regarding new product design and development as well as design transfer activities\.
The individual reports directly to the Unit Quality Manager for the business unit\. The individual works cross\-functionally with business unit management, as well as their respective teams on matters related to new product design, design transfer, risk management, process/product design, and quality improvement projects & plans\.
The major activities of the individual are:
+ Design Assurance: Quality Planning \(i\.e\. new product development, design excellence, and design transfer\)\. Ensures that all design control and production / process control projects meet applicable regulatory \(local and international\), Corporate, and Unit requirements
+ Design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file maintenance\.
+ Champions and drives Lifecycle Risk Management throughout the business unit
+ Design risk management: Assure that appropriate risk management tools \(i\.e\. FMEA’s\) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices\.
+ Design control excellence: Continuous monitoring and improvement of the design control program/process to ensure best\-in\-class processes\.
+ Change control: Ensure change control projects are comprehensively evaluated and executed per the change control process\.
+ Regulatory compliance: Regulatory compliance projects/initiatives, as assigned, in accordance with FDA QSR’s \(21 CFR Part 820\), ISO 13485, CMDR, MDD/EU MDR, J\-PAL and ISO 14971\.
+ Supplier audits: Evaluation of new suppliers to support design and development and to drive supplier improvement efforts\.
+ CAPA: Initiating and directing corrective and preventive actions to problems/issues relating to process and/or product quality, such as complaint resolution, customer interface, and regulatory action\.
+ Inspection/Audit coordination: Assisting the BU and Plant Management Representatives in preparation for third party audits \(i\.e\. FDA inspections, notified body audits\) and in the effective closure of findings resulting from such audits\.
+ May provide guidance and work direction to junior quality engineers
+ The effectiveness of this position can be measured by the health state of Unit Quality Assurance \(e\.g\. successful new product design launches\) and critical activities/projects, as assigned, that contribute to the success of the business\.
+ Up to 15% travel may be required\.
+ Requires a Bachelor of Science degree in Engineering from an accredited four \(4\) year university\. An alternate bachelor’s degree with relevant quality/engineering experience may be considered\.
+ Requires a minimum of 6 years of experience in the following areas: Quality Engineer in the medical device field, design assurance quality support, medical device manufacturing and design, medical device validation, risk management activities, regulatory compliance, statistics and sampling methods, and CAPA root cause analysis\.
+ Minimum of 3 years’s experience in a regulated industry \(medical device/pharmaceutical\)
+ Consistent application of technical principles, theories, concepts and quality sciences / tools, Proven problem solving skills, Project management & people skills, excellent verbal & written communication skills, strong multi\-task & situational management, personal & group leadership, strong interpersonal skills, excellent computer skills, system management, strong results orientation, and ability to thrive in a fast paced, improvement oriented business\.
+ Strong in the application of statistics\.
+ Strong familiarity with regulatory requirements \(FDA 21CFR820, ISO 13485, CMDR, MDD/EU MDR, and J\-PAL\), particularly Design control and Risk Management \(ISO14971\)\.
+ Statistical software \(Minitab\) knowledge and Six Sigma Methodology a plus\.
+ ASQ Certification\(s\) \(e\.g\. Quality Engineering/Auditing\) preferred\.
+ Experience with FDA Pre\-Market Approval \(PMA\) a plus\.
- Primary Work LocationUSA IL \- Vernon Hills
- Additional Locations
- Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.