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Title: Quality Systems Specialist II (Non Conforming Material & Complaint Mgmt.)
Location: Vadnais Heights, MN
Shift: Day shift (Monday-Friday, 7AM-3:30PM)
Compensation: $70,000 + 5% annual bonus
Benefits: Company offers an exclusive benefits package including Medical, 401k, and PTO.
Vaccine Requirement: No COVID19 vaccine requirement.
Position Description: Quality Systems Specialist II
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 the company. Provides input for process improvements and efficiencies, shows sound decision making and good time and project management.
Responsibilities/Duties include but are not limited to:
• Graphics and Labeling Requirements: Reviews, redlines and creates label content based on customer requirements and company policies
• Process owner for label control and reconciliation, ensuring that documentation of label application and scrap is accurately captured and recorded
• 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
• Nonconforming Material Requirements: Reviews and supports evaluation of all reported material non-conformances (prior to material release) ensuring appropriate segregation, disposition and corrective actions are implemented
• 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)
• CAR/CAPA Requirements: Reviews and investigates requested or assigned CARs/CAPAs
• Internal Audit Requirements: Supports and/or conducts compliance and requirement audits of Quality System processes, manufacturing areas, and documentation as assigned
• Presents findings to process or area management as well as to company management as needed
• External Audit Requirements: Supports Quality System Manager in managing external audits (customer and regulatory)
• Equipment and Gage Control Responsibilities: Manages equipment/gage calibration resources or sends out for calibration and ensures records and calibration labels are appropriately controlled according to Calibration procedure.
• 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.
• 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
• 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.
• Supports Quality activities by: Supporting Quality Objectives as they relate to job responsibilities
• Performs other duties as assigned by immediate supervisor.
• Job Closing Responsibilities: Review of MOM for customer requirements relating to documentation requirements (inspection data, production information, raw material CoCs, company CoCs, etc.)
o High school diploma;
o Minimum 2 years of experience production environment;
o Familiarity with quality management systems (21CFR820, ISO 9001/13485), specifically with respect to handling of nonconforming product;
o Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems including Epicor and Master Control.
o BA/BS in Life Science or related discipline;
o Familiarity with complaint handling, root-cause investigation, product change control;
o Knowledge of FDA Quality System Regulation (QSR), ISO 13485:2106, and associated standards.
o Up to 5+ years of experience working in a regulated industry, such as medical devices or aerospace.
• 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.
• 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.