Viant, a leading manufacturer of medical devices, is looking for a Quality Engineer III to join their Collegeville, PA team.
Some of the benefits to you:
- Competitive compensation
- Benefits package (starting day 1) that includes: medical, dental, vision and 401(k) with company match (401k after 90 days)
- Paid time off and holidays
- Greater stability – Viant recently doubled in size and is investing heavily in their facilities
- 180,000 sq. ft.
- Tube-manufacturing equipment, metal deformation machines, laser processing & Swiss machining equipment
- AS-9100, ISO 13485 certified
- Metal tube manufacturing and fabrication
- ECM/ECG tube cutting
- Swiss machining
- Laser cutting
- Cleaning and finishing
- Experience with root cause analysis, DOE, statistics, lean manufacturing, trending, Risk Management, and Six Sigma methodologies
- Proficient in Microsoft Office and Minitab
- A winning attitude, strong interpersonal skills, and demonstrated success in living the “continuous improvement” philosophy and driving change within cross-functional teams
- Ability to work independently with minimal direction
- Ability to effectively communicate in both written and verbal form
- Ability to manage time and priorities effectively to ensure on-time completion of tasks
- Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), or Six Sigma Green Belt or Black Belt desired
- Familiarity with metals processing and the Toyota production business model helpful, but not required
Please click Apply or email your information to: email@example.com
- Adhere to company Core Beliefs and all safety and quality requirements, including, but not limited to: company Quality Management System (QMS); Environmental, Health & Safety; company policies, procedures, and work instructions; and other relevant regulatory requirements.
- Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Monitor manufacturing of assigned products, ensuring compliance with DMR and quality system requirements, and ensure complete and correct Device History Records are maintained.
- Identify, prioritize, and implement product and process improvement initiatives.
- Review the adequacy and correctness of changes to Bills of Material (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Generate and lead the completion of protocols and reports for product, process, and test method validations.
- Partner with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where required and/or appropriate.
- Develop various inspection techniques and procedures to ensure product integrity to design specifications. Write and implement Incoming, In-Process, and Final Inspection procedures.
- Ensure that the disposition of non-conforming materials comply with all relevant requirements, and ensure that appropriate corrective actions are implemented to prevent recurrence.
- Lead complaint investigations and manage appropriate remediation activities.
- Review quality data for potential CAPA’s, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses.
- Assist with product transfers.
- Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control, including Cpk, DOE, Hypothesis Testing, etc.
- Perform other functions as required.
About the company: With over 35 years of medical device molding experience, Viant has become a comprehensive solutions provider for single use medical devices. Services range from concept and design of components to assembly of finished products. They are headquartered in Foxborough, MA and operate 17 manufacturing facilities in the US, with additional locations in China, Mexico, Costa Rica, Puerto Rico, France, Germany and the UK.
All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.