Company: BIO FILM INC
Posted on: June 25, 2022
Let's Create Something Great! We make an impact globally. We are a
leading medical device company with headquarters in Vista CA. Our
facility researches, manufactures and is a producer of innovative
healthcare products. Come work with us to create great things! What
we offer: 4-day work weeks - every Monday off! Optional partial
remote schedule (up to 50%/week depending on role) Health, dental,
and vision insurance plans with employee contribution.
Reimbursement Account and Flexible Spending Account Matching 401K
and profit-sharing Discretionary annual bonuses based on profits
Generous PTO and holiday schedule including paid time off from
Christmas Eve to New Year's Day Annual professional development
opportunities and tuition reimbursement Does this sound like you?
Passionate about teamwork, driven by exceeding expectations, thrive
in a fast-paced environment, like to have fun! Apply Today for our
Quality Engineer Role! This is not an IT role but it is a quality
focused role. Quality Engineer is responsible for... working with
the internal manufacturing engineers, supply chain and contract
manufacturers to continuously improve performance of key system
components (refine life cycle, reduce scrap, improve/repair
processes) by implementing process controls and developing quality
control plans. Responsible for the overall Quality, Risk, and
Performance Management of suppliers and contract manufacturers. The
QE tracks data, identifies improvement projects, and manages cross
functional implementation to improve performance in Production and
Supplier Quality. The QE has high upstream focus to limit cost and
time investment maximizing Product Quality.
- PRODUCTION QUALITY, INCLUDING MONITORING AND CONTINUOUS
IMPROVEMENT BY IMPLEMENTING & DEVELOPING QUALITY CONTROL PLANS,
PROCESS CONTROLS AND UTILIZING APPROPRIATE QUALITY TOOLS.
- PERFORMANCE MANAGEMENT OF SUPPLIERS AND CONTRACT MANUFACTURERS,
INCLUDING LEADING SUPPLIER AUDITS.
- DRIVING EFFECTIVE MANUFACTURING EQUIPMENT QUALIFICATIONS,
PROCESS CAPABILITY EVALUATIONS AND PROCESS VALIDATIONS, INCLUDING
COLLABORATING WITH THE MANUFACTURING ENGINEERS IN PROTOCOL
GENERATION, REVIEW AND EXECUTION.
- ADMINISTRATION OF THE RISK MANAGEMENT PROGRAM, INCLUDING
DEVELOPING PLANS, PHLS AND FMEAS.
- LEAD IN ROOT CAUSE INVESTIGATIONS AND DRIVING EFFECTIVE
CORRECTIVE AND PREVENTATIVE ACTIONS. Requirements:
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
- BS IN ENGINEERING, CHEMISTRY, BIOLOGY, BIOTECH, CHEMICAL ENG,
OR OTHER SCIENCE RELATED FIELD
- 3+ YEARS OF EXPERIENCE IN A SUPPLIER OR PRODUCTION QUALITY
- EXPERIENCE WORKING IN A REGULATED ENVIRONMENT WITH A STRONG
KNOWLEDGE OF MEDICAL DEVICE FDA 21 CFR 820/ISO 13485:2016
- WORKING KNOWLEDGE OF QUALITY SYSTEMS AND QUALITY RELATED TOOLS,
SUCH AS FMEA, SPC, CPK, AQP, DOE. DESIRED EXPERIENCE:
- PRIOR SUPPLIER AND INTERNAL AUDITING EXPERIENCE.
- KNOWLEDGE OF 21 CFR 210/211 REGULATIONS.
- PROCESS VALIDATION AND IQ/OQ/PQ EXPERIENCE.
- AQL/STATISTICAL SAMPLING EXPERIENCE.
- DESIGN CONTROL EXPERIENCE.
- DESIGN V&V EXPERIENCE.
- ASQ CERTIFICATION, CQE, CSQP, AND/OR CQA OR LEAD AUDITOR
- KNOWLEDGE OF ISO 14971.
- PRACTICE IDENTIFYING, MITIGATING, AND RESOLVING RISKS (PHL,
- LEAN SIX SIGMA TRAINING.
- KNOWLEDGE OF STATISTICAL SOFTWARE (MINITAB, JMP).
- SCAR, CAPA, NCMR, AND CUSTOMER COMPLAINT INVESTIGATION AND ROOT
CAUSE ANALYSIS EXPERIENCE (FISHBONE, 5 WHYS).
- EXPERIENCE WITH PACKAGING SUPPLIERS AND CONTRACT
- PROJECT MANAGEMENT SKILLS. PI182675153
Keywords: BIO FILM INC, Vista , Quality Engineer, Engineering , Vista, California
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