Fresenius Medical Care North America Senior Quality Systems Engineer in Oklahoma City, Oklahoma
Senior Quality Systems Engineer, Renal Solutions Inc., a Fresenius Medical Care N.A. company, Oklahoma City, Oklahoma
Responsibilities include the coordination, administration and control of all aspects of the quality systems function for engineering operations, as well as quality compliance and government regulatory filings. Will engage in daily collaboration with the design team to render guidance in the quality process and review documentation to ensure compliance with federal regulations.
Principal Dutiesand Responsibilities:
Coordinatestimely and complete engineering investigations within the manufacturing plant.
Ensurescompliance with all state and federal manufacturing regulations andrequirements.
Composesand executes engineering design and process verification and validationprotocols and reports.
Providesexpert subject-matter advice on quality issues for propriety products andmethods to design engineers, validation engineers, and other personnel.
Investigatesroot cause solutions for product release through nonconformance reports (NCR),corrective and preventative actions (CAPA), material containment and hold forms(MCH) and affected lot hold forms (ALH).
Utilizesstatistical techniques, Experimental Design (DOE), Risk Management, HazardAnalysis and Critical Control Point (HACCP), and Failure Modes and EffectsAnalysis (FMEA).
Conductsand interprets Gage Reproducibility and Repeatability (R&R) studies.
Providessupport in coordinating plant risk management activities and ensuring riskmanagement techniques are implemented throughout product lifecycle.
Ensuresthat the Supplier Management procedures are clearly defined and implemented tofulfill regulatory and business requirements. Identifies areas for continuousimprovement of these procedures.
Providesin-house training (e.g., calibration, validations, and compliance) inconjunction with other personnel.
Participatesas a member of the facility’s Audit Team in performing internal and externalaudits.
Usesappropriate statistical methodology, such as CpK (Process Capability) and trendanalysis, to assist in analyzing or reviewing manufacturing, quality, and/orlaboratory data for recurring problems or the detection of trends.
Establishesreports and procedures in conjunction with Process Engineering to assure systemreliability and product quality. When recurring problems and/or negative trendsare identified, recommends corrective action for problem resolution.
Makesimprovements to our organization's engineering processes to eliminate causes ofproduct and manufacturing non-conformities.
EducationExperience and Required Skills:
Position requires a Bachelor’s degree (or an equivalent foreign degree) in Industrial or Manufacturing Engineering and 4 years of experience as a Quality Systems Engineer. Must also have 2 years of experience (which can be gained concurrently with the above listed experience requirement) with the following: (i) standard quality improvement tools; (ii) QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, CFR 210/211, ICH Guidance, ISO 14971, and ISO 13485; (iii) quality assurance components of full product development lifecycles, design change, and document change control; (iv) FDA inspections or ISO audits; (v) process verification and validation methodologies, manufacturing/production process control methodologies, and risk management and regulatory requirements related to the assessment of product and process changes; and (vi) Quality Management System tools and continuous improvement methodologies.