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Title: Quality Engineer
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Quality Engineer - REMOTE WORK
Requires XP with med device, 13485, CAPA, internal audits, data analytics, FDA, and cGMP.
- Location: REMOTE (prefer east coast hours), can be flexible on the hours in the work schedule though (need to be day time hours)
- Job Function: Product Quality Engineering (PQE)
- Position Reports to: Manager, Quality Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – 2-3 months
- Pay rate: 60-70/hr.
- Job Location: Hopkinton or Remote
- Job# bh11532
- Date Posted: 7/15/2020
Provide quality support for product Lifecyle management. Responsible for development activities of medical device 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
- The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- 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 per ISO 14971:2019: Risk Management Plans, pFMEA’s, Risk Control, etc. for new and released products.
- Supports nonconformance investigation, disposition and release activity as applicable
- Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes
- Assists with the review of complaints to determine potential adverse events
- 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 regulations (i.e., MDR, IVDR)
- 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)
- The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- 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.
- 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 the Medical Device industry desired.
- Knowledge of ISO 13485 and ISO 9001 is essential as well as FDA and cGMP regulations and documentation practices
Knowledge of Risk Management and applicable standards
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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