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Sr. Quality Engineer
2 weeks ago
This is a hands-on on-site (non-remote) position that will support the customer experience (and drive sales growth) by working to mitigate risk through detection and prevention at both a product and systems level. The position requires a solid understanding of Structured Problem Solving and Quality Control tools and concepts and will help implement and continuously improve those practices as well as the ability to balance priorities, drive accountability and action and communicate in a detailed and real-time manner. This role requires a strong knowledge base of pre-production documentation requirements for the aerospace and medical device industries. The sphere of interaction regularly includes new product introduction team, quality team, front-line employees, at times customers, suppliers and cross-functional roles or leadership.
AUTHORITY:
This position receives sufficient authority from and is accountable to the Quality Manager or appointed designate for the successful completion of assigned duties and responsibilities. The Senior Quality Engineer has the authority to act necessary to address departures from the quality system or metrological procedures, so long as such action does not deviate from established company guidelines, is consistent with sound technical and business judgment, and follows the practices of the organization.
ESSENTIAL FUNCTIONS AND BASIC DUTIES:
1. Create and implement quality procedures, control plans, PPAPs (production part approval process), PFMEAs (process failure mode effects analysis) specifications, standards, data collection, metrics, and other quality tools to ensure products meet or exceed customer requirements.
2. Work closely with the new product introduction team to ensure smooth transition of parts from the quoting phase up through manufacturing and shipment to the client.
3. Mentor other members of the Quality Engineering team to ensure that they can carry out their tasks in a timely manner.
4. Serve as senior site liaison to customers, suppliers, and subcontractors regarding quality issues and concerns as appropriate, which will involve coordination with other sites and some travel (
5. Analyze failures to meet requirements, determine corrective and preventive actions based upon risk evaluations, and use a structured problem-solving template such as 8D to document and correct issues.
6. Ensure timely resolution of discrepant material reports (DMRs), client complaint investigations (CPAs), and other reports as relevant to this position.
7. Strive to maintain a low quantity of parts to be actively dispositioned by quality and keep materials moving through the process.
8. Develop and recommend inspection and sampling techniques or other risk mitigation activities for new and existing customers and parts as necessary to reduce scrap, rework, and other process wastes.
9. Provide technical assistance as it relates to process capability, Gage R&R execution and investigation, new product introduction, defect detection & prevention, and process controls.
10. Coordinate and communicate plans and activities to drive a "team" approach where needed within the organization.
11. Communicate clearly, concisely, and professionally to management and staff both orally and in written form.
12. Assist in the training of staff via local and online based training programs.
13. Assist with variance reduction, troubleshooting, and improvement initiatives as needed throughout the business.
14. Follow and ensure all guidelines, SOPs, and procedures of MultiSource Manufacturing are met by site staff.
15. Ensure that proprietary techniques are not disclosed to non-employees except as approved in writing by the Leadership Team.
16. Maintain a perpetual state of readiness and willingness to respond to the queries and needs of clients, staff, subcontractors, and colleagues.
17. Promotes the company image through the exercising of sound and ethical business practices as related to the public and our customers.
18. Remain current on technical, industry, and business advancements and trends as suggested by the Quality Manager and other Leadership Team members.
19. Perform other duties as assigned and assist the Quality Manager as needed.
QUALIFICATIONS
EDUCATION/EXPERIENCE: Six-year degree in a technical field with 3 years' experience or four-year degree in a technical field with 5 years' experience.
• Working knowledge of regulated environments and requirements such as FDA, ISO and AS9100
• Experience with audits including external clients and regulatory agencies as well as internal assessments.
• Proven expertise with SPC, Gage R&R, GD&T, PFMEA, DOE, PPAPs, Control Plans, and qualification processes such as IQ/OQ/PQs
• Understanding of manufacturing and assembly methods such as fixtures, tooling, and fabrication & gaging methodology and metrology
• Ability to transform raw data into conclusions and recommendations.
• Skilled in Excel and other basic MS Office applications
SKILLS and ABILITIES:
• Influence and effectively communicate (written and verbally) with a wide variety of personnel and roles. Excellent internal & external customer services skills.
• Conduct structured problem solving, manage time, prioritize competing demands, and escalate as needed.
• Quickly learn new concepts, software, interfaces, and tools
• Translate minimal direction into action, work independently, adapt to change, be curious and open-minded.
OTHER REQUIREMENTS:
PHYSICAL STRENGTH: No heavy lifting required.
LANGUAGE ABILITY: Able to read and follow instructions in English.