Job Listing: Quality Engineer

Designs, installs and evaluates quality assurance process sampling systems, procedures and statistical techniques; designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards; recommends revision of specifications when indicated; formulates or helps formulate quality assurance policies and procedures. May conduct training on quality assurance concepts and tool. Interfaces with all other engineering components within the company and with customers and suppliers on quality related issues.

Essential Duties and Specific Responsibilities (other duties may be assigned):
- Establish and verify via audits the effectiveness of critical QC checkpoints for system, assembly and component manufacturing.
- Evaluate prototype products
- Evaluate product design and manufacturing processes with respect to design controls and quality related activities during design transfer.
- Establish Quality Assurance release criteria for product and system performance.
- Evaluate adequacy of test methods and review validation studies.
- Document all aspects of product design and development to meet ISO standards and FDA QSR requirements.
- Work with internal project management to obtain appropriate resources and coordination with other departments and projects to assure timely completion of project tasks.
- Member of MRB, CO, and CAPA Boards /Teams, as assigned.
- Conduct complaint investigations.
- Establish sample retain program.
- Back up for QC and Technical Services.
- Technical and administrative oversight of contamination control testing.
- Analyze quality metrics for improvement.

Supervisory Responsibilities: May direct the work of QC/QA staff. May receive the delegated signature and department authority for QC, QA, and QE by the VP-Quality & Regulatory Affairs.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- (1) Technical knowledge of molecular biology, including searching and analysis of genetic databases, principles of nucleic acid hybridization, probe and primer design, molecular cloning and enzymatic amplification of specific gene sequences.
- (2) Experience with product design controls during development of nucleic acid-based assays for disease detection and diagnosis or development of pharmaceutical products in a regulated environment, preferably in a company manufacturing diagnostics products for the clinical lab and/or doctor’s office market.
- (3) Organizational, planning and detail follow-up skills required.
- (4) Experience in planning, coordinating and documenting controlled studies, including protocol.
- (5) Training and experience in basic statistical analysis tools and Design of Experiments (DOE) methodology preferred.
- (6) Ability to work in a multi-functional team environment.
- (7) Ability to handle and resolve conflicts and work under schedule/milestone pressures.
- (8) Demonstrated ability to lead fast track investigations through analysis to outcomes for decision.
- (9) Ability to understand complex scientific concepts.
- (10) Demonstrated ability to be flexible and resourceful. Good communication, technical writing, and diplomacy skills required.
- (11) Knowledge of safety precautions required for working with bloodborne pathogens at Biosafety Level 1 and 2.
ASQ Certification as CQE, CQA, and / or CQM preferred.

Education and Experience: To qualify as a Quality Engineer B.S. minimum; advanced degree preferred in the sciences, life sciences, or engineering and 5 or more years of relevant experience as a scientist or engineer, in molecular biology, biochemistry, applied engineering or a related field. In rare occasions, a highly qualified and experienced individual with a B.S. degree and 10 or more years of relevant experience will.

Required Skills for Quality Engineer Job:

About Aerotek CE:

Join Aerotek CESM, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek CE offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek CE team! Allegis Group and its subsidiaries are equal opportunity employers.