What are the responsibilities and job description for the Quality Engineer position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Description:
- The Quality Engineer is responsible for maintaining a good vendor/customers relationship by consistently exceeding customer specifications, throughout proper product development and supply in a world-class condition. All systems/criteria shall be developed, documented, and maintained to ensure consistent quality assurance.
Essential Duties and Responsibilities:
- Maintains adherence to product quality standard in department for incoming materials and finished goods
- Identifies and records any problems relating to product, process, and quality system
- Coordinates Customer Approved 3rd Party Quality System Requirements
- Initiates, recommends, or provides solutions through designated channels
- Manages reduction of further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected
- Represents the Company to our Customer and vendors, including quality-related supplier visits and contacts as approved by the Quality Manager
- Makes independent decisions/referrals to resolve potential quality problems when appropriate
- Assists in development/adherence of Quality Manual and Quality Lab set-up
- Thinks, resolves, and documents all quality issues in a disciplined, 5-phase process
- Analyzes data and performance, and evaluates quality of incoming and outgoing product
- Controls product quality through development and use of FMEA's, Control Plans, Flow Charts, and SPC
- Creates computerized graphs/reports that clearly demonstrate quality characteristics
- Compiles and submits sample submissions to Customer; receives and reviews sample submission from vendors
- Understands, operates, and performs minor repairs on various types of laboratory test equipment and checking fixtures
- Evaluates supplier PPAP package
- Maintains "operator documents” and QC records
- Maintains flexibility in ability to adjust to changes in job requirements and hours while completing other functions on a daily basis without fail
- Reports to Quality Manager as well as Department Managers to keep all informed of issues
- Reads blueprints
- Assists in problem solving
- Performs functional quality tests as required
Education Required and Preferred:
- BS degree in a technical discipline or equivalent experience required
- ASQC/CQM/CQE certification preferred
- Experience Required and Preferred:
- 3-5 years of quality engineering experience preferred
Language Skills:
- Ability to read and interpret documents such as safety rules, blueprints and procedure manuals. Candidate has the ability to write routine reports and correspondence.
Mathematical Skills:
- Ability to add, subtracts, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Candidate has the ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability:
- Candidate has the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Other Skills and Abilities:
- Must be computer literate and familiar with appropriate software programs. Candidate has the ability to create visual aids for communication purposes.
Additional Information
All your information will be kept confidential according to EEO guidelines.
