Quality System Specialist II

Innovize•Saint Paul, MN

56d

About The Position

Summary: Quality position primarily focused on achieving compliance with Quality System requirements. Works under the direction of the Quality System Manager to implement Quality System requirements for assigned Quality System processes including, but not limited to, Change Control, Post Market Quality, Handling Nonconforming Material, CAR/CAPA, Equipment/Gage Calibration &Preventive Maintenance, Environmental Controls, Record Management, Internal and 3rd Party Audits, Graphics/Labeling, Job Closing and Production Support. Quality Position is stratified into three different skill levels of advancement: Level 1: Entry level with basic skill set, requires close oversight and management of work responsibilities by Quality Manager. Level 2: Midlevel position with work experience and knowledge allowing individual to work with less oversight by Quality Manager. An employee who has become competent in one or more processes and provides leadership and mentorship on these processes within the Quality Group as well as within the company. Provides input for process improvements and efficiencies. Shows sound decision making and good time and project management. Level 3: Senior position with expertise in multiple processes and ability to work independently, providing support and mentorship or supervision to others in the department as well as providing leadership within the organization. Minimal oversight is required by this position with employee showing a self-directed work style and leadership within and outside the Quality Group. Solid decision-making skills are demonstrated. Employee actively improves processes and compliance status.

Requirements

High school diploma;
Minimum 3-5 years of experience production environment;
Familiarity with quality management systems (21CFR820, ISO 9001/13485), specifically with respect to handling of nonconforming product;
Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems including Epicor and Master Control.

Nice To Haves

BA/BS in Life Science or related discipline;
Familiarity with complaint handling, root-cause investigation, product change control;
Knowledge of FDA Quality System Regulation (QSR), ISO 13485:2106, and associated standards.
Up to 5+ years of experience working in a regulated industry, such as medical devices or aerospace.

Responsibilities

Follows all Quality procedures and policies ensuring that Quality System requirements are achieved in an ethical manner.
Maintains current knowledge of applicable regulations and standards associated with the Quality System.
Maintains current understanding and compliance with applicable process procedures and company policies.
Meets commitments on time, in full, and with accuracy and attention to detail.
Reviews, redlines and creates label content based on customer requirements and company policies
Works with Change Control to ensure revised labeling is properly controlled and documented
Utilizes software to generate and issue labeling as required by production
Process owner for label control and reconciliation, ensuring that documentation of label application and scrap is accurately captured and recorded
Supports control of customer supplied labels
Maintains label generation equipment
Support corporate standards and ensures regulatory requirements for any finished medical device product labeling is met
Supports Speed to Market teams at product transfer and Production teams relative to product changes:
Review redline and update job jackets, MOM and other documents to implement product changes
Utilize ERP system to document change review and approvals
Updates ERP system as needed with product change information
Ensures that training is appropriately updated and recorded for changes implemented
Supports customer notification of changes initiated by company
Supports Quality Team and Management relative to Document Control and Change Management:
Process document create/revise to implement Quality System changes
Utilize document control software to manage controlled procedures (active and archived)
Ensures that training is appropriately updated and maintained in software system associated with Quality System Training and documentation changes
Maintains records and external documents per applicable procedures
Maintains external documents associated with product including supplier documentation
Maintains external documents associated with Quality System
Maintains Quality System records in accordance with retention policies
Reviews and supports evaluation of all reported material nonconformances (prior to material release) ensuring appropriate segregation, disposition and corrective actions are implemented
Communicating both internally and with customers as needed, regarding material issues and dispositions
Utilizes ERP system to document, track and trend nonconformance information
Supports the production teams in ensuring timely resolution of nonconforming material
Ensures that disposition actions are completed and verified in timely manner (according to procedure)
Works closely with Engineering groups for technical support on evaluations and disposition actions.
Reviews and investigates all customer returns, complaints, and customer requests for support relative to product conformance ensuring appropriate disposition and corrective actions are implemented in timely manner (according to procedure)
Utilizes Epicor to document, track, and trend post market information
Communicates both internally and with the customers as needed to resolve product issues
Supports customer needs relative to vigilance reporting, product failure investigation, and regulatory inquiries regarding product
Works closely with Engineering groups for technical support on investigations and corrections
Reviews and investigates requested or assigned CARs/CAPAs
Coordinates investigations for root cause and development of appropriate corrective actions
Ensures that documentation (paper and Epicor) is accurate, consistent, and complete
Ensuring that procedural timeframes are met to ensure timeliness of the process
Utilizes Epicor to track and trend corrective action implementation and closure
Communicates both internally and with customers as needed regarding CAR/CAPA status and effectivity
Supports and/or conducts compliance and requirement audits of Quality System processes, manufacturing areas, and documentation as assigned
Utilizes knowledge of external and internal requirements to assess compliance
Assesses and reports on impact of nonconformities found
In addition to reporting nonconformities found, identifies areas or opportunities for improvement
Presents findings to process or area management as well as to company management as needed
Works with auditees to develop appropriate corrective actions for nonconformities found.
Tracks and trends audit details and closure in Epicor ensuring timely closure of actions and the audit report per procedure
Supports Quality System Manager in managing external audits (customer and regulatory)
Provides subject matter expertise in areas of responsibility
Acts as scribe (note taker) and/or runner (facilitates retrieving information and personnel needed for audits)
Conducts pre-audit review of areas and documentation in support of audit preparation
Participates in developing corrective actions to address any nonconformities found
Supports documentation of audit in Epicor along with any corrective actions needed and ensures timely closure of actions to ensure audit can be closed in a timely manner
Manages Calibration for equipment and gages:
Manages equipment/gage calibration resources or sends out for calibration and ensures records and calibration labels are appropriately controlled according to Calibration procedure.
Investigates any out of tolerance findings and coordinates appropriate corrective actions
Supports organization in maintaining and controlling measurement equipment in use, supporting tracking process and periodic inspections for fitness of use and addressing questions or concerns raised by users
Maintains supplier files for all calibration service providers
Maintains records of calibrations in Epicor
Supports control of equipment PMs and work standards:
Works with organization to create work standards within the scope of production transfer and continual improvement initiatives
Controls work standards and manufacturing aides according to company procedures
Reviews Preventive and unanticipated maintenance reports to assess for impact to product and validations
Conducts fit for use inspections of inspection workmanship binders, visual boards and inspection templates
Works with organization to investigate any out of tolerance, lost or damaged equipment and coordinates appropriate corrective actions, customer notifications, and documentation
Conducts and/or facilitates air, water, and/or surface monitoring for viable and/or particulate counts to monitor against standards or specifications. Works with outside supplier to complete cleanroom and HEPA testing.
Trends data, supports excursion investigations and actions, writes reports relative to monitoring
Communicates results to area management, company management and customers as needed
Ensures timely completion of monitoring and actions per company procedure
Supports Quality activities by:
Supporting Quality Objectives as they relate to job responsibilities
Receptive to cross training within the Quality System Specialist position
Advocate for the company's safety program in daily activities
Proactively looks for ways to improve Quality processes and documentation
Performs other duties as assigned by immediate supervisor.
Review of completed job jackets for accuracy, completeness and compliance to requirements per established procedures.
Review of MOM for customer requirements relating to documentation requirements (inspection data, production information, raw material CoCs, Innovize CoCs, etc.)
Preparing and compiling required documentation for inclusion in product shipments to customers.
Performance of final product release in Epicor.