Quality Engineer

Oberg Industries•Sarver, PA

4h•Onsite

About The Position

At Oberg Medical, quality isn’t inspected in at the end—it’s engineered from the start. We’re looking for a Quality Engineer who thrives in precision environments and enjoys partnering with manufacturing, customers, and suppliers to ensure world-class products for the medical, aerospace, and advanced manufacturing markets. Under limited supervision, the Quality Engineer ensures customer quality requirements are met and supports the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with ISO 9001, AS9100, ISO 13485, and 21 CFR Part 820. As a Quality Engineer, you’ll be hands-on and highly collaborative, supporting both day-to-day quality activities and long-term system improvements.

Requirements

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.

Nice To Haves

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

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.