Post Market Quality Engineer (Winston Salem)

ConvaTec in Winston Salem, NC

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
  • $78,130.00 - 122,480.00
position filled
The Post Market Quality Engineer is responsible and accountable for quality engineering deliverables required within the post market compliance & surveillance processes.
Act as a steward for post-market safety and quality, customer requirements/expectations, and regulatory compliance.
Support R&D, Operations, Marketing, Clinical Affairs, Regulatory, Post Market Surveillance, external customers and equipment suppliers.
Timely and accurate presentation of complaint analysis to all stakeholders, while concurrently leading root cause analysis for any issues identified.

Duties and Responsibilities

  • Support quality engineering activities for all post market product surveillance including collection, analysis, and evaluation of product safety and performance data, and detection of trends in data that may warrant further action.
  • Execute and maintain procedures and processes to address post-market surveillance activities such as product investigations, periodic and ad hoc risk reviews, and product monitoring (trending and tracking) across all product franchises.
  • Develop understanding of the current risk profile for all products including reportable product harms and malfunctions.
  • Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products while providing expertise in product complaint history and occurrence levels.
  • Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, third party inspections, and other business processes by applying typical quality/problem solving tools such as fishbone/cause & effect, Pareto, process mapping, etc.
  • Support continuous improvement of quality engineering procedures, processes, and tools.
  • Principal Contacts

    Internal R&D, Operations, Marketing, Clinical Affairs, Regulatory, Post Market Surveillance

    External Customers, raw materials and component suppliers, contract manufacturers and equipment suppliers

    Travel Requirements

    Position may involve travel up to 10% of the time, mostly within Europe and the Dominican Republic, but the ability to perform global travel is expected. Most trips will include overnight travel.

    Language Skills Required

  • Speaking Yes English (English required; Spanish preferred)
  • Writing/Reading Yes English
  • Education/Experience/Qualifications

  • BS/BA degree in engineering or life sciences
  • Project Management Training
  • Advanced MS Excel skills, including the ability to independently create and utilize pivot tables and charts, formulas, V-lookups, and other advanced data manipulation
  • Requirements:

  • At least 3 years experience in quality engineering role in a medical device or life sciences technology driven company (5+ years preferred)
  • Experience with various phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization
  • Experience in product and process risk management
  • Experience in post-market surveillance activities (tracking and trending, investigations)
  • Significant regulatory and compliance knowledge and expertise in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211.
  • Strong proficiency in MS Visio, Minitab and MS Project
  • High level of personal and professional integrity and trustworthiness with strong work ethic
  • Ability to work independently with minimal direction, while producing quality work with a high level of accuracy and attention to detail
  • Ability to maintain composure and focus while managing multiple priorities, changing workloads, and meeting critical deadlines
  • Excellent communication, presentation, and facilitation skills.
  • Ability to work effectively within cross-functional team environments.
  • Support a positive working environment that encourages creative thinking and intelligent decision-making.
  • Proficient with general office software such as Word, Power Point, and Project, as well as statistical tools (e.g. Minitab).
  • Strong MS Excel skills, including the ability to independently create and utilize pivot tables, formulas, V-lookups, and other advanced data manipulation
  • Passion for ongoing product and compliance learning as well as skills enhancement.
  • Desirable but not required:

  • Certified Quality Engineer (CQE)
  • Project Management Professional (PMP) certification
  • Lean Six Sigma Green Belt (LSSGB) or Black Belt (LSSBB)
  • Working Conditions

    This position is office based but will require work in a clean room manufacturing facility which produces medical device and wound care products. Use of proper clean room attire is required.

    ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

    Notice to Agency and Search Firm Representatives: ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

    Associated topics: bio, biochemistry, bioengineering, biological engineer, biomaterials, biophysics, bioprocessing, enzyme, molecular, pain

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