Lead Quality Systems Specialist

Fresenius Medical Care•Lawrence, MA

5d•$117,000 - $196,000•Hybrid

About The Position

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. This role 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. The specialist will train other staff members, act as a back-up for the manager, identify risks and evaluate deficiencies, and facilitate internal training on quality assurance requirements, processes, and procedures. Audits and risk assessments may also be performed. The role involves working on problems of diverse scope where data analysis requires evaluation of identifiable factors, demonstrating good judgment in selecting methods and techniques for obtaining solutions, and networking with senior internal and external personnel. The individual receives little instruction on day-to-day work and general instructions on new assignments. They will act as a back-up subject matter expert, provide assistance to lower-level staff with more complex tasks, and mentor other staff as applicable. The specialist will review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations, and assist with various projects as assigned. Additional responsibilities may include focus on one or more departments or locations, with specific functions detailed in an applicable addendum.

Requirements

Bachelor’s Degree required.
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.
Prior corrections and removals experience required.
Proficient understanding of USA, Health Canada and Mexico regulations.

Nice To Haves

Advanced Degree preferred or an equivalent combination of education and experience.

Responsibilities

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.
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.
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.
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.
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.