Connexion Systems and Engineering, your Boston staffing experts, would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:
- Responsible for receiving, reviewing, and processing product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy. This position combines skills in post market regulation, statistics, and product knowledge in the process of trending and handling incoming complaints. Partners with Product Support / Quality Engineering or other investigators on product investigations and trends.
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.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues, including fulfillment, assay and instrument complaints.
Responsible for escalated complaints. May place material on quality hold, after approval by QA Management.
- Facilitates moderate to complex investigations.
Conducts timely and insightful response to investigations.
- Performs department metrics and works with others to ensure department goal are met.
- Prepares agendas, facilitates cross functional meetings and creates meeting minutes with supervision.
- Engages owners on determination of effective CAPA.
- Works with TS or Field Service to ensure appropriate required information is documented in complaint.
- Works on problems of moderate to major in scope where analysis of situation or data requires a review of a variety of factors.
- Leads cross functional projects with supervision
- Works with other PMSS and PMSE to ensure consistency in documenting complaints.
- Ensures that complaints are assessed from MDR within 3 days of receipt.
- Assist in external & internal audits.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Works with R&D to determine specific product and incident complaint codes.
- Works on transfer of information for new products to the rest of the PMS team.
- Participates on Post Launch Surveillance teams (PLST).
- Reviews other customer communication (response letters, acknowledgement letters) as appropriate.
- Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
- Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
- Builds productive working and team relationships.
Acts as mentor to other Post Market Specialists; assists in new employee training.
- Creates or update QMS documents,
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- 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/moving and carrying products weighing up to 40 pounds.
- Exposure to moving mechanical parts, vibration and/or moderate noise levels.
- Exposure to hazardous chemicals or other materials.
- Safety Shoes with Impact and Compression Protection Must be worn.
- Exposure to blood.
- Bachelor’s Degree in a healthcare related field preferred.
- Minimum one to two years of related experience in the healthcare/device industry or exposure to medical device quality system regulations understanding of drug/device
Is this contractor required to track project codes for the work outlined in this requisition?
Date Posted: 6/13/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Quality Engineer
Location: Danbury, CT
Employment Type: Full Time, Contract
Pay Range: 30-34/hr.
Duration: 6 months+
Job #: bh10077
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776