8170 Embury Rd Grand Blanc, MI 48439 US
Quality Assurance Engineer
What we value
- Integrity. We do what is right.
- Accountability. We do what we say.
- Customer First. We deliver extraordinary experiences.
- One Global Team. We before me, always.
- Inspired. We love what we do.
What you will do
- Assist in management of complaint handling system including intake, evaluation, coordination of investigations, maintenance of complaint records, development and presentation of trending reports, and regulatory reporting of device incidents.
- Daily focus on improving, implementing, and maintaining quality system in manufacturing environment e.g. calibration, product inspection and controls, and final product releases.
- Assist in Material Review Board activities ensuring proper trending, closure of issues and dispositions are appropriately addressed. Drive continuous improvement initiatives based on MRB data.
- Support in the development and maintenance of various quality system documents and records, including Device Master Records, Technical Files, QA System Release Records.
- Support QA aspects of design and development of medical devices including compilation, review, and approval of device design history files, risk management reports, coordinate design verification/design validation.
- Define, develop and manage various quality projects and validation studies to ensure compliance with global regulatory requirements.
- Assist in management of supplier qualification and supplier oversight programs. Perform external (distributor & supplier) quality assessments as needed.
- Support quality system audits and inspections performed by third parties such as EU Notified Body and regulatory authorities, including FDA.
- Support ongoing compliance of internal quality system programs including:
- Management Review
- Employee Training
- Corrective and Preventive Actions
- Internal quality audits
- Support the generation and maintain documents including; engineering drawings, labeling, IFUs, etc.
- Other duties as assigned.
What you will need
- High attention to detail and accuracy.
- Proficient with metrology and metrology tools and equipment.
- Must be able to work efficiently and in an organized manner.
- Proficiency in creating and manipulation of Excel spreadsheets & Word documents and statistical analysis software.
- Must have good communication skills, both oral and written.
- Working knowledge/experience with lean manufacturing principles.
- ASQ Certified Quality Engineer (CQE) or other Quality Certifications Desirable.
- Minimum of 3 years’ experience in direct engineering support of quality management systems for medical device and manufacturing of sterile devices, (US & EU) class I, II devices.
- Working knowledge of FDA Quality System Regulation (21 CFR 820), EU Medical Devices Regulation (2017/745) & ISO 13485, ISO 14971, ISO 11135.
- Certified Quality Engineer (CQE) is a plus.
- Bachelor’s degree in an engineering discipline (Mechanical Engineering is preferred).
- Experience in process engineering/validation/test method development.
- Excellent organizational and record keeping skills.
- Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative and management personnel.
- Internal and external quality auditing experience is desirable.
- Proficiency in information technology applications such as MS Word, Excel, PowerPoint.
- Proficiency in AutoCAD system a plus.
Pay Rate Range: $20-$50/hr. Salary will be dependent on experience
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.