Quality Engineer

Butler County, PA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Quality Engineer
Location: On-site Oberg Medical Sarver PA

At Oberg Medical quality isnt inspected in at the endits engineered from the start. Were 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 youll be hands-on and highly collaborative supporting both day-to-day quality activities and long-term system improvements.

Essential Duties and 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.

Qualifications:

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.

Experience & Education:

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.
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

Work Environment & Physical Requirements:

Combination of office and manufacturing environments.
Regular interaction with production areas.
Ability to sit or stand for extended periods.
Must be able to wear required PPE (safety glasses hearing protection safety shoes)
On-site collaboration is required this is not a remote role

Why Oberg:
At Oberg youll work with cutting-edge technology complex components and a collaborative team that values precision accountability and continuous improvement. We invest in our people and provide opportunities to grow your skills while making an impact in highly regulated high-reliability industries.

What Oberg Industries Offers:

Competitive pay (above industry average)
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

About Oberg Industries:
Oberg Industries LLC is a local family-owned contract manufacturer and supply chain integrator providing tooling/metal stamping and precision machining services to many well-known companies around the passion is for precision manufacturing and our breadth of expertise enables us to provide cost-effective manufacturing solutions for the most demanding and complex production challenges for our customers. Our highly trained workforce plays a pivotal role in our ability to produce high quality parts. At Oberg Industries you will join a team of amazing people who treat each other like family while working with products that are improving and saving peoples lives each and every day. Learn more about our award-winning organization by visiting .

At Oberg Industries LLC we are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion gender national origin genetics pregnancy disability age veteran status or other protected characteristics. No question on this application form is intended to solicit information about an applicants protected characteristics if addition the Americans with Disabilities Act requires employers to provide reasonable accommodations for known physical or mental disabilities of applicants.

Required Experience:

Manager

Quality EngineerLocation: On-site Oberg Medical Sarver PAAt Oberg Medical quality isnt inspected in at the endits engineered from the start. Were looking for a Quality Engineer who thrives in precision environments and enjoys partnering with manufacturing customers and suppliers to ensure world-cl...

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.

Qualifications:

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.

Experience & Education:

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.
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

Work Environment & Physical Requirements:

Combination of office and manufacturing environments.
Regular interaction with production areas.
Ability to sit or stand for extended periods.
Must be able to wear required PPE (safety glasses hearing protection safety shoes)
On-site collaboration is required this is not a remote role