Job Code Quality Engineer, Sr Duties Sr QE Design Assurance
Location: Natick MA Duration : 6 months *Project Description:* Author Design Control SOPs and Work Instructions based on applicable Design Control Regulations (21CFR 820.30, ISO 13485, etc) Use input from multiple sources (regulations, user community input, subject matter experts, existing documents, etc.) to develop complete set of Design Control work instructions. *General Summary:* Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide quality engineering support within technical development concepts, new product development, operational, or system/services support. Collaborates with Quality management to recommend, design and implement functional process improvements. May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate. *Duties and Responsibilities:* · Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation. · Champion departmental or cross-functional engineering initiatives. · Provide project direction, coaching, and mentoring for engineering and technical team personnel. · Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. · Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements. · Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. · Act as leader or team member in supporting quality disciplines, decisions, and practices. · Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. · Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues. · Advise management on potential improvements or enhancement to quality systems and processes in the company. · Identify strategies and lead activities that advance the state-of-the-art of the BSC design control process and its understanding and practice throughout the company. These include compliance, best practices, and integration within the Quality System. · Establish new and enhance existing relationships with design control stakeholders at all levels to promote understanding and effective application of the process. · Provide training, coaching, and technical support to design control subject matter experts and practitioners. * * *Working Conditions:* General office environment, with occasional domestic and international travel to other BSC facilities and or/meetings and conferences. *Competency Expectations:* · *Must be thoroughly familiar with the FDA, ISO, MDD requirements associated with developing Medical Devices in a regulated industry.* · * **M**ust have experience in authoring quality related SOPs and Work Instructions.* *· Broad understanding of US and International regulations including ISO 14971:2009, 21 CFR, 820, 210, 211, and 11 is required, as well as ISO 13485:2003* · Excellent communication (oral and written) and presentation skills (articulate and persuasive). · Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships. · Mentors and coaches others in technical areas. · Proficient with Microsoft Office Suite *Education Minimum Education & Experience:* · MS in Engineering/Technical field preferred. MBA is also preferred. · 8-10 years of technical experience, 3-5 years minimum in medical device industry including experience in implementing Design Controls on product development teams · ASQ certification is a plus. *Best Regards,* *Allen Paul** *|* **ProSoft Technology Group, Inc. IM*:allen_recruiter** *Emai:[email protected]*|* Phone* 630.371.0530 x 142 |* Fax* 630.725.1900 |* Toll free* 800.727.9778 ** 2001 Butterfield Rd, Suite 305, Downers Grove, IL, 60515 | * * www.prosoftgroup.com This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to which they are addressed. If you have received this email in error please notify the system manager. Please note that any views or opinions presented in this email are solely those of the author and do not necessarily represent those of the company. Finally, the recipient should check this email and any attachments for the presence of viruses. 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