Quality Systems Specialist II

Job Description

Job Description

Title: Quality Systems Specialist II

Reports to: Quality Systems Manager

Summary: The Quality Systems Specialist II is responsible for implementing the 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. This Quality Systems Specialist II will have work experience and knowledge allowing individual to work with less oversight by the Quality Systems Manager. This Quality Systems Specialist II is competent in one or more processes and provides leadership and mentorship on these processes within the Quality Group as well as within Innovize. Provides input for process improvements and efficiencies, shows sound decision making and good time and project management.

Duties/Responsibilities include but are not limited to:

Graphics and Labeling Requirements:

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

Change Control and Record Requirements:

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

Nonconforming Material Requirements:

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.

Post Market Requirements

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

CAR/CAPA Requirements:

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

Internal Audit Requirements:

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

External Audit Requirements:

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

Equipment and Gage Control Responsibilities:

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

Production Support Responsibilities

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

Environmental and Product Monitoring Responsibilities:

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.

Job Closing Responsibilities

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.

Training/Education/Experience

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.

Preferred

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.

Physical Requirements:

Must have acute vision including close vision for inspections.

Regularly required to sit as well as climb or balance, stoop, kneel and crouch.

Must be able to work in manufacturing environments exposed to moving mechanical parts and restricted gowning requirements.

Must occasionally lift and/or move up to 25 pounds.

Competencies/Talents/Personal Attributes

Ability to effectively interact using outward mindset with a wide range of personalities and across many levels of the organization.

Ability to prioritize and drive multiple activities and adapt to changing business needs;

High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal supervision.

Well-developed written and verbal communication skills in English.

Ability to effectively presenting information (written and verbally) to senior managers and team members.

Strong technical writing ability;

Able to explain complex/technical matters;

Strong reasoning and investigative skills with the ability to solve problems.

Technical aptitude to work with equipment and tools including measurement equipment such as calipers, microscopes, and test equipment.

Notes: This Job Description is intended to be an accurate reflection of the current job as of the document effective date. This job description is not intended to be an exhaustive list of all required skills, duties, responsibilities, or qualifications associated with the positions described herein. The company reserves the right to revise or amend the qualifications, functions and duties of the jobs or to require that additional or different tasks be performed if business circumstances change. Employees are held accountable for performing the duties of their position, as evaluated by documented scorecards and performance management reviews based upon company specified metrics and goals documented in the scorecard for which the employee is made aware and maintains.

Job Posted by ApplicantPro

Full-time