Lead Quality Systems Specialist

PURPOSE AND SCOPE:

Acts as a subject matter expert to support the organization with initial compliance and ongoing preparation, testing, and monitoring of conformance to established quality systems processes and standards for manufacturing and production.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• A seasoned, experienced professional with full understanding of quality systems; resolves a wide range of issues in creative ways.

• Performs high level evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.

• Trains other staff members

• Responsible as back-up for manager when manager is not available

• Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.

• Facilitates internal training on quality assurance requirements, processes, and procedures.

• May perform audits and risk assessments.

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

• Networks with senior internal and external personnel in own area of expertise.

• Normally receives little instruction on day-to-day work and general instructions on new assignments.

• Acts as a back-up subject matter expert

• Provides assistance to lower-level staff with more complex tasks that require a higher level of understanding of functions.

• Escalates issues to supervisor/manager for resolution, as deemed necessary.

• Mentors other staff as applicable.

• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.

• Assists with various projects as assigned by a 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.

• The individual will, for the most part, be seated and work at a computer and utilize telephone equipment.

• Travel may be required, as necessary.

SUPERVISION:

• None

EDUCATION:

• Bachelor’s Degree required. Advanced Degree preferred or an equivalent combination of education and experience

EXPERIENCE AND REQUIRED SKILLS :

• 6 – 8 years’ related experience or an equivalent combination of education and experience.

• Highly autonomous. Minimal supervision required.

• Self-starter with the ability to work well both independently and as part of a small team.

• Can prioritize tasks accordingly.

• Very detail-oriented, well organized, and driven to meet deadlines and program goals.

• Strong verbal and written communication skills.

• Good computer skills with knowledge of Microsoft Office including Access, email platforms, ERP software, and Microsoft Outlook

• Ability to work in a high stress environment given the nature and process.

• Ability to generate moderately complex spreadsheets with graphs for trending data and presentations.

• Knowledge and application of metrics and charts for quality system processes.

• Excellent project prioritization, planning, and management.

Corrections and Removals

• Ensures effective Recall Strategy (includes Customer and internal communications), Recall Tracking, and Recall Termination.

• Responsible for monthly recall status updates to FDA.

• Ensures timeliness of invoice payment submissions on outside vendor services.

• Back-up keynote speaker to PQTF Monthly meetings on C&R Recalls.

• Product Safety Committee participant and back-up host.

• Responsible as back-up for manager when manager is not available

• Supports FADF, HHA, and Field Action Notification (Safety and Alert) creation activities.

• Back- up for witnessing, documenting, and coordinating recalled material destructions with outside vendors and internal departments.

• Utilizes judgement and discretion to determine when a recall is ready for termination.

• Oversees and maintains all field action campaigns in Access Database

• Mentors and trains subordinate employees.

• Maintains consignee lists within Access Database

• Assists with data collection and distribution of FMCNA Field Action Data.

• Responsible for Monthly Recall Tracker meeting with management.

• Ensures timeliness of recall strategies as outlined in approved field action decision.

• Responsible for timeliness of Complaint Related Returned Goods Material (CRM RGA) dispositions.

• Supports all Corporate Quality Holds Department activities including execution, verification and distribution of hold/dispositions.

• Establishes effective relationships with ORA District Recall Coordinators and vendors to ensure robust recall execution.

• Maintains Pre and Post Market Surveillance industry practice understanding through development trainings.

Experience and Required Skills:

• Prior corrections and removals experience required.

• Proficient understanding of USA, Health Canada and Mexico regulations.

ADDENDUM:

Management Control Element (MCE)

• Collaborates with sites on Management Responsibility processes, Management Review Process, Quality Planning, ISO Audits, and Regulatory Inspections.

• Responsible for continuous improvement of Corporate Quality Systems MCE policies, procedures, and work instructions associated with the Quality Manual, Management Responsibility, Management Review, Quality Planning, Organizational Structure and Regulatory Inspections.

• Prepares Corporate Management Review and Corporate Quality Council presentations and meeting minutes. Tracks and reports on action items. Ensures presentation materials are aligned with corporate requirements.

• Monitors Management Review process to ensure adherence to procedural requirements and report to management.

• Establishes efficient and effective process for collection of management review data across FMCRTG, LLC sites.

• Tracks Management Representatives and Alternate Management Representatives across FMCRTG, LLC sites, ensuring appointment letters are accurate.

• Executes Quality Planning process at corporate location, including tracking of actions against plan deliverables.

• Supports and provides guidance on the Quality Planning process at the corporate and site locations.

• Collaborates with sites to develop metrics and trending data to ensure adherence to the Quality Planning procedural and plan requirements and report during management review meetings.

• Implements training program for Quality Planning at corporate and site locations.

• Prepares information required for inspections and audits based on level of inspection, commitments, and agendas.

• Participates in various Regulatory Inspections and Audits by interfacing with investigators and auditors; assists front/back office.

• Provides assistance at corporate and site locations with the preparation of regulatory responses, ISO responses, and internal audit responses and associated periodic updates

• Provides assistance with the documentation, organization, tracking, and maintenance of responses and updates associated with Regulatory citations, ISO findings, and Internal Audit findings

• Assists with CAPAs assigned to Quality Systems, Management Control Element department.

Education

• Professional quality discipline certification (CQE, CQA, CQM or RAB) desired.

Experience and Required Skills:

• Strong knowledge of FDA regulatory requirements (21 CFR Part 820/210/211 and Part 11).

• Knowledge of ISO 13485 and Canadian Medical Device Regulations (CMDR).

• Prior experience with Regulatory inspections (back office, front office).

ADDENDUM:

Documentation

• Responsible for the overall health, security, and function of the documentation system and provides back up in SAP Master Data activities as directed. Supports the documentation discipline by ensuring the integrity, accuracy, completeness, and quality of documentation and compliance to regulatory guidelines.

• Maintains company documentation including appropriate change control functions. Assists in expediting approval and the distribution of Change Notices (CNs). Tracks, logs, and distributes CNs to maintain paper trail for new and revised documents to ensure compliance with regulations.

• Creates Standard Operating Procedures and interacts with various functions of the organization.

• Maintains documentation system with continuous improvement initiatives as identified.

• Ensures all documents are filed in appropriate location and document control is maintained and effective.

• Performs “Proofing” review during Change Notice (CN) submission/document check-in process to ensure basic requirements are met for specifically required elements.

• Develops/maintains standard document forms/templates to ensure the organization’s needs for documentation infrastructure are met, with compliance to all applicable statutory and regulatory requirements.

• Addresses business and technical support inquires of Documentation Management System users.

• Develops and provides training across the business as required.

• Provides assistance and guidance to CN originators for new part numbers BOMs, as well as changes to existing SAP data, or other CNs. Coordinates workflow to create, process, and make approved changes to SAP data in CNs.

Experience and Required Skills:

• Experience in a regulated industry in a documentation/engineering change control environment.

• Basic understanding of Engineering specifications and drawings. AutoCad experience strongly preferred.

• Expert knowledge/understanding of regulatory requirements governing document control preferred.

• Basic knowledge of 21 CFR Part 11 compliance is a plus. Knowledge of Documentation Management Sciences/Mil-Specifications

Physical Demands and Working Conditions:

• Lift document files up to 40 pounds required

ADDENDUM:

Quality Systems Training

• Responsible for the design, development, delivery, and evaluation of both traditional classroom and e-learning instruction. Manages projects and provides guidance and support to other staff.

• Conducts ongoing and comprehensive Learning Management System (LMS) training needs assessments.

• Designs learning activities and materials. Applies knowledge of instructional methods, adult learning theory, and instructional design techniques. Develops evaluation and performance measurement tools to measure post-learning knowledge, retention, and behavioral outcomes.

• Develops and implements elements of a competency-based training program (competency mapping, job task analyses, etc.).

• Develops and analyzes KPIs and metrics to evaluate overall program effectiveness.

• Identifies measurable objectives/outcomes and develops instructional materials (presentations, in-class activities, assessments, e-learning modules, documentation, work instructions, OJTs).

• Designs and delivers highly engaging, creative, and effective classroom/online instruction.

• Provides support during FDA and other regulatory body inspections.

Education

• Bachelor’s Degree in Instructional Design, Education, or related field a plus.

Experience and Required Skills:

• Experience in Learning and Development or Training environment required. Dynamic group presentation skills.

• Strong background in instructional design, development and delivery strongly preferred.

Quality Systems E-Learning Development

• Responsible for the design, development, delivery, and evaluation of e-learning instruction. Manages projects and provides guidance and support to other staff.

• Designs learning activities and materials. Applies knowledge of instructional methods, adult learning theory, and instructional design techniques. Develops evaluation and performance measurement tools to measure post-learning knowledge, retention, and behavioral outcomes.

• Develops and analyzes KPIs and metrics to evaluate overall program effectiveness.

• Identifies measurable objectives/outcomes and develops instructional materials (presentations, assessments, e-learning modules, documentation, work instructions, OJTs).

• Designs and delivers highly engaging, creative, and effective online instruction.

• Provides support during FDA and other regulatory body inspections.

Education

• Bachelor’s Degree in Instructional Design, Education, or related field a plus.

Experience and Required Skills:

• Experience in Learning and Development or Training environment required.

• Strong background in instructional design, development and delivery strongly preferred.

• Knowledge/experience in the implementation of robust training evaluation models preferred.

• Knowledge of instructional technologies. (enterprise LMS, e-learning course development)

• Experience working in a regulated industry and/or in the delivery of GxP or Quality Systems training a plus.

• Working knowledge of the requirements of 21 CFR 820/211 and ISO 13485:2003 a plus.

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

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Annual Rate: $94,700 - $157,000.00

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

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

Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors