Quality Systems Engineer

PURPOSE AND SCOPE:

Responsible for representing the sites quality initiatives and compliance objectives in the development of methods, procedures, validations and quality planning for the facility.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Under close supervision, utilizes established procedures to perform routine assigned tasks and applies company policies and procedures to participate in the development, review, and improvement of the facility's Quality Plan and manufacturing processes. Participates in management of product Risk Management Files. Continually updates information and coordinates information exchange with other FMCNA facilities.
• Utilizes current acceptable industry/FDA requirements to justify, write, and implement process validation and GMP procedures. Drafts, reviews, and/or assists in the implementation of validation protocols, final validation reports, Quality System procedures, performance qualifications, and Engineering Change Orders (ECO). Maintains validation records and systems to keep ongoing process validations current and applicable to process.
• Performs plant investigations into product complaints and prepares reports for review by Quality Manager prior to submittal to Corporate Quality Systems. Assists in drafting Corporate Material Review Board (MRB) request to deviate, when appropriate, from current corporate documents.
• Analyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified, investigates and assists in making recommendations necessary to correct and prevent recurrence.
• Uses appropriate statistical methodology, such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality, and/or laboratory data for recurring problems or the detection of negative trend. Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality. When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution.
• Reviews processing procedures in new and existing programs to assure enhanced quality and productivity while remaining in compliance with FDA/cGMP/QSR. Assists the Quality Systems and Production operations with compliance to QSR requirements.
• Participates in management of the plant metrology program to assure all appropriate tooling is available for inspection and test, and that all calibration activities are performed when due.
• Participates as a member of the facility's Audit Team in performing internal and external audits as required.
• Assists in providing in-house training (e.g., calibration, validations, batch production and operation of equipment) in conjunction with plant management to operators and other personnel, as assigned.
• Participates in product design control activities for new product lines.
• Conducts risk analysis (Fault Tree, FMEA, FMECA, HASAP or equivalent accepted methods) as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.
• Has the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible production, stocking, or shipping of discrepant assemblies or product arises.
• Builds stable working relationships internally.
• Normally receives specific, detailed instructions on all work.
• May refer to senior staff, if applicable, for assistance with day-to-day problems that may arise.
• Escalates issues to supervisor/manager for resolution, as deemed necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by direct supervisor.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• May be required to sit and/or walk for considerable lengths of time. Bending to floor level is required.

EDUCATION:

• Bachelor's Degree required, preferably in Engineering, Science, Chemistry, or Biology. An Associate's Degree may be considered with additional years or relevant work experience.

EXPERIENCE AND REQUIRED SKILLS:

• 0 - 2 years' of combined Quality Engineering, process validation required. Pharmaceutical manufacturing, medical device manufacturing and/or laboratory (organic chemistry, analytical, and/or microbiology) experience preferred. With a Master's Degree no prior work experience may be necessary.
• Knowledge of process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/CMP/QSR), Risk Management / HACCP concepts, statistical process control, and statistical problem solving. Also as applicable, strong knowledge of Health Canada GMP's.
• Must have good organizational skills and be able to perform work with little supervision. Position requires a mathematical aptitude with a good background in algebraic skills and statistical analysis skills. Knowledge of analytical laboratory methodologies is important.
• Professional auditing certification (ASQ, CQA, RAB, or equivalent) preferred for audit responsibilities.
• FMCNA IMPAQ Associate or equivalent (i.e. Six Sigma Green Belt) qualification is preferred; professional quality science certifications (i.e. ASQ, CQE, CMQ/OE) desired.
• Good verbal and written communication skills to make oral presentations and write technical reports.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.