Oberg Industries · 7 hours ago
Quality Engineer
Oberg Industries is a family-owned contract manufacturer specializing in precision manufacturing. They are seeking a Quality Engineer to ensure customer quality requirements are met and to support the maintenance and continuous improvement of the Quality Management System in compliance with industry standards.
Industrial EngineeringMachinery ManufacturingManufacturing
Responsibilities
Develop and maintain quality documentation including inspection plans, inspection criteria, FMEA, Frist Article (FA), PPAP, Gage R&R, qualification, and validation reports
Support and maintain the Quality Management System in compliance with ISO 9001, AS9100, ISO 13485, and 21 CFR Part 820
Partner with Manufacturing and Program Management during contract review and process development to ensure repeatable and capable processes
Develop, implement, and maintain statistical process data (SPC, capability studies) to drive inspection strategies and process improvements
Lead and support process validations (IQ, OQ, PQ) and technical documentation
Investigate customer complaints and nonconformances; develop effective corrective and preventive actions (CAPA)
Conduct and support internal, external, product, and process audits
Lead MRB activities and disposition of nonconforming product (upward delegation only)
Perform supplier audits as required
Interface directly with customers and suppliers, both remotely and on-site
Support calibration system deployment and maintenance
Use PC-based and automated inspection equipment (CMM, OGP, surface analyzers, etc.)
Assist with APQP during new product development
Participate in inspection activities as needed to ensure parts meet dimensional and visual requirements
Establish in-process inspection procedures when required
Maintain accurate documentation and product/process history records
Qualification
Required
Strong working knowledge of MS Office (Excel, Word, PowerPoint, Access)
Strong statistical analysis and working knowledge of SPC tools (Minitab, QC-Calc, or similar)
Excellent written and verbal communication skills
High attention to detail and documentation accuracy
Must be a U.S citizen and able to comply with U.S. export regulations
Minimum of 5+ years of experience in Quality, preferably as a Quality Engineer in Medical device manufacturing, contract manufacturing, or aerospace or a four-year college degree with relevant experience
Hands-on experience in regulated quality environments such as, ISO 9001, AS9100, ISO 13485, and/or FDA QSR required
Experience with First Articles, FMEA, PPAP is required
Preferred
Experience with precision measurement tools (CMM, OGP, drop gauges, surface analyzers) preferred
Quality Engineer certification preferred
Internal or supplier audit experience a plus
Lean manufacturing or Six Sigma certification a plus
Benefits
Medical, dental, and vision insurance (100% premium coverage)
Health Savings Account (HSA)
Opt-out reimbursement for medical coverage
401(k) with up to 4% company match
Annual Profit-Sharing contributions
Paid time off and holiday pay
Overtime pay (after 8 hrs./day worked)
Annual increases
Quarterly bonuses
Flexible start times
Air conditioned, temperature-controlled environment
Clean, bright, and modern facilities
High focus on family, work-life balance
Opportunities for career development and growth
Collaborative and safety-focused work environment