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Sr. Quality Engineer
Ref No.: 18-13614
Location: Brooklyn Park, Minnesota
Start Date: 10/11/2018
Position Title:
Quality Engineer/Quality Technician

JOB FUNCTION: Summarize the function(s) of the job and reflect the basic purpose why the position exists.

Provide engineering support in the development and maintenance of the company's quality system. This position is responsible for practicing and assisting in ensuring company wide compliance with the Quality System procedures and requirements and lead the development of quality plans, CAPAs, supplier qualifications and support verification and validations. Additionally, this individual is responsible for supporting incoming inspection through training, component throughput, material review and prioritizing inspection activities.

PRINCIPAL RESPONSIBILITIES: Describe the job duties; indicate percentage of time spent, indicate with an asterisk the essential functions. Indicate the frequency by which they are performed: (AS - as assigned, D - daily, W - weekly, M - monthly, Q - quarterly, SA - semi-annually, A - annually). Begin each statement with an action verb.

The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all-inclusive.

# Essential Frequency
(AS, D,W,M,Q, SA, A) % of Total
Time Description
1 * D 25 Coordinate inspection related activities in support of other departments' functions and requirements including performing inspections or tests of purchased parts. Coordinate the reporting, analysis, and resolution of material non-conformance incidences including active participation in Material Review Board and other meetings as needed. Support and coordinate supplier related quality activities to ensure continued improvement. Perform inspections or tests of
2 * D 25 Adhere to design control procedures, general safety rules, company policies and procedures, Good Manufacturing Practices, and FDA regulations including the qualification and implementation of Document Changes Notices involving product or process changes.
3 * W 15 Manage the Complaint System including completion of product evaluations and investigations, ensure Complaints are evaluated and closed in a sufficient manner
4 * W 10 Monitor and support calibration and maintenance of all test equipment and fixtures and operation of equipment. Serve as coordinator for Calibration system. This includes issuing Purchase orders, maintaining Calibration log, coordinating calibration activities, reviewing certifications and updating calibration log.
5 * W 10 Plan, initiate, conduct and manage projects, including quality projects, in support of company's strategic plan independently or in cross-functional teams. Complete projects in a manner consistent with corporate objectives.
6 * AN 10 Serve as back up for Documentation Coordinator
7 * A 5 Conduct quality audits and develop subsequent preventive action programs, including appraisal and approval or disapproval of suppliers.

EDUCATION, EXPERIENCE, SKILLS: List minimum level required to perform the job competently:

• BS in Engineering (Quality Engineer) or equivalent experience in Quality Assurance (Quality Technician)
• Knowledge of QSR, MDD, ISO13485:2003, CMDR.
• At least two years' prior experience in Medical Device.
• ASQC certification (engineering, auditing, technician, inspector) strongly preferred
• Proven experience with supplier management (Quality Engineer)
• Manufacturing / Design experience with the following being a strong plus (Quality Engineer):
o Process control
o Risk Assessment / FMEA

• Strong working knowledge of basic Quality Assurance
• Strong computer skills in Microsoft Office (including Word, Excel, Outlook, and Project)
• Strong organization, interpersonal, and communication skills
• Self directed, resourceful, detail oriented and able to manage multiple priorities
• Able to work in a fast paced and results driven environment
• Able to work independently or as a leader of projects
• Able to influence individuals without supervisory authority and motivate outside contractors and vendors
• Able to objectively identify technical problems and create solutions
• Ability to read, write and comprehend English

Special Training: Quality Systems Manual, Documentation System; QSR, MDD, CMDR, ISO14971, ISO13485:2003.

• Must be able to remain in a stationary position 75% of the time.
• The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery, etc.
• Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer
• The person in this position frequently communicates with internal and/or external contacts. Must be able to exchange accurate information in these situations.
• Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
• Significant work pace & pressure due to deadlines.
£ 10% travel.
• Biological hazards associated with returned/contaminated product
• Light work, exerting up to 20 lbs of force or less.
• Requires fingering, repetitive motion, talking and hearing.
• Significant work pace & pressure due to deadlines.