Quality EngineerLocation of Work Grand Blanc, MIEmployment Type Full Time EmployeeJob DescriptionOur missionAt Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.Our brand promiseWe deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
Remarkable service: A seamless, personal process designed around you and your needs.
Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.
Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.
Our people promiseExcellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.Job Purpose Summary
We are seeking a Quality Engineer with an entrepreneurial spirit who excels in a dynamic, growth-oriented environment to join our team.
What you will do
Assist in management of the 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 the 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, and 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.
REQUIRED EXPERIENCE/EDUCATION:
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.
Hands on experience in quality system documentation.
Will work in a manufacturing environment on the shop floor.
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.
What we value
Customer First - We deliver extraordinary experiences.
Accountability - We do what we say.
Integrity - We do what is right.
Inspired - We love what we do.
One Global Team -We before me, always.
Join us today and Excel@Corza !Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.