Provide quality support for product Lifecyle management. Responsible for development activities of products following design transfer requirements and internal procedures. Provides general engineering services and support for product manufacturing and quality control. The PQE is provided limited direction from the Manager to maintain the complaint and investigation processes and is capable of performing all activities and takes a leadership role with projects and product support.
Essential Duties and Responsibilities:
Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action
Facilitate and actively contribute to the risk management activities Management Plans, pFMEA’s, Risk Control, etc. for new and released products.=
Supports nonconformance investigation, disposition and release activity as applicable
Creates appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
Assists with the review of complaints
Assists with the department metrics and works with others to ensure department goals are achieved
Remediation of product documentation for changes in product compliance for new or updated standards
Identify, investigate and implement corrective and preventive actions (CAPAs)
Participate/Lead projects related to Design Transfers
Review technical product documentation including device master records (DMRs), drawings, bills of materials, test protocols and reports, manufacturing work instructions,?engineering?change orders (ECO), etc.
Work with manufacturing?engineer/process?engineer?to ensure process controls are in place
Review and/or approve reports for: test method validations, design transfer, pilot production, and process validations (IQ, OQ, PQ)
Write, review and / or approved quality plans to support product activities both internal and external
Assist in external & internal audits
Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)
Bachelor’s degree or higher in related discipline. Relevant work experience may offset the educational requirement
Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus
7+ years of experience as a Quality Professional in ISO 9001 industry desired
Knowledge of ISO 9001 is essential; knowledge of ISO 13485, IVDR/IVDD and FDA and cGMP regulations and documentation practices desired
Knowledge of Risk Management and applicable standards
Sit; use hands to finger, handle or feel objects, tools, or controls
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl
Lifting/pushing/pulling and carrying products weighing up to 45 pounds
Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels
Potential Exposure to hazardous chemicals or other materials
Personal Protective Equipment (PPE) compliant with site specific policies/procedures must be worn in designated areas
Potential Exposure to blood
Onward Search is an equal opportunity employer, dedicated to a policy of non-discrimination in an employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances. Candidates must be at least 18 years old to be considered for employment. EOE/M/F/D/V/SO.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
The client is unable to support 1099 / Corp-to-Corp or Independent Contractor arrangements at this time. All freelancers will be paid as W2 employees.
Onward Search is a drug-free workplace.