Overview
Casting Quality Assurance Specialist Jobs in Reedsburg, WI at Grede Reedsburg Facility
*** Please note, this is a Temporary role until 2026***
Location: Rocklin, CA
Hours: Full-time, Monday – Friday, 8am – 5pm
Pay rate: $25 – $27, based on experience
Roles that are responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for quality, documentation and processes as well as continuous improvement and preventive activities. Conducts analytics to ensure that the company’s products are according to defined quality standards.
PRIMARY OBJECTIVE OF POSITION:
The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system. This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual. This position is multi-disciplinary with opportunities to work on future products and current product and process improvements. The position may represent Quality on cross-functional teams to support business needs driving a positive site quality culture. The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.
Essential Duties and Responsibilities
Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual.
Performs project review and audit of Device History Files (DHF’s) and technical files including:
o Stability protocols and reportso Summary of Safety and Performance reportso Risk Management plans, reports, FMEAso Post-Market Surveillance plans and reportso Performance evaluation plans and reports including scientific, clinical, and analytical documents.o Product composition reportso Sensitivity and specificity/Repeatability and reproducibility reportso Specification reportso General Safety and Performance Requirement reportso Etc.
Performs review of data and records supporting the DHF while assessing for good documentation and record keeping practices ensuring appropriate requirements are met.
Obtains information for clarification from process owners while providing appropriate and relevant feedback.
Coordinates files upon completion of review for upload into EDMS as necessary.
Electronically signs as technical approver for quality on applicable documents and within the validated electronic databases.
Write, revise and/or review Standard Operating Procedures.
Maintain extensive knowledge of Standard Operating Procedures and policies.
Supports internal and external audits as required.
Understands, supports, and communicates Company mission, vision, and values.
Understands and follows the requirements of the quality system.
Maintains current training requirements.
Trains other staff members as requested.
Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
Recommends, provides, or initiates solutions by actively providing suggestions for improvement.
Must be willing and able to work on weekends or extended hours as needed.
Follows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDD/IVDR, and compliance to the site Quality Manual.
Review and approve quality documentation and records.
Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues.
Other duties as assigned or required.
What we offer:
With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
MilliporeSigma is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.
Job Types: Full-time, Contract
Pay: $25.00 – $27.00 per hour
Schedule:
8 hour shift
Day shift
Monday to Friday
Work Location: In person
Title: Casting Quality Assurance Specialist
Company: Grede Reedsburg Facility
Location: Reedsburg, WI
