Quality Engineer (6679) Job in Trenton 30752, Georgia US
Accellent, Inc. is a fully integrated provider of design, supply chain management and strategic sourcing services to the Medical Device industry. Accellent, www.accellent.com, a recognized market leader, is a fast-growing outsource manufacturing and design solution company specializing in high growth areas such as Cardiology, Endoscopy and Orthopaedics. The top Medical Device companies partner with Accellent to provide innovation, advanced technology, speed to market, low cost labor and strategic sourcing. We’re looking for team players with a can-do attitude to share in our vision and corporate values. Accellent offers competitive salaries; a comprehensive benefits package, and a stimulating work environment.
Description
Accellent, Inc. is a fully integrated provider of design, supply chain management and strategic sourcing services to the Medical Device industry. Accellent www.accellent.com, a recognized market leader, is a fast-growing outsource manufacturing and design solution company specializing in high growth areas such as Cardiology, Endoscopy and Orthopaedics. The top Medical Device companies partner with Accellent to provide innovation, advanced technology, speed to market, low cost labor and strategic sourcing.
We are seeking a Quality Engineer for our Trenton, GA facility.
Responsibilities:
- Provide Quality Engineering support for engineering project development.
- Provide quality project management support as needed for product transfers from development to production.
- Develop and support Supplier Quality Engineering program.
- Provide Quality Engineering support for manufacturing.
- Review document and procedure changes for quality requirements and compliance with the quality system.
- Develop quality systems and procedures as needed.
- Provide quality support for the disposition of material.
- Develop and implement IQ, OQ and PQ protocols to ensure compliance with the Quality System.
- Provide initiative and support for SPC, FMECA, and DOE as applicable.
- Support the implementation of continuous improvement initiatives for productive processes.
- Designee for Management Representative, as assigned.
- Comply with all work rules including those pertaining to safety, health, and quality.
- Perform other duties as necessary.
Required Experience
Qualifications:
- Typically Bachelors degree in engineering, equivalent degree or extensive work experience
- 2-5 years experience in manufacturing, preferably medical devices, pharmaceuticals, aerospace, food, automotive or other regulated industries, including at least three years leadership responsibilities with increasing responsibility in quality assurance or associated fields.
- Must be familiar with and understand recognized regulations and standards such as (where applicable)
- • US– 21 CFR Part 820 (FDA QSR, cGMP)
- • ISO 13485 – (EN) ISO 13485 Medical Devices – Quality Management Systems
- • EU – Medical Device Directive (MDD) 93/42/EEC
- • EU – Active Implantable Medical Device Directive (AIMD) 90/385/EEC
- • EU – In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC
- • ISO 13485 under Canadian Medical Device Conformity Assessment System (CMDCAS)
- • ISO 14971 Risk Management
- • AS9100 Aerospace
- • ISO 9001 Quality Management Systems
- Able to be technically comprehensive and knowledgeable including standard business ERP system principles, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerencing and mechanical drawings and associated software packages.
- Familiar with Six Sigma and/or a history of lean manufacturing, Kaizen and 5S, etc. Six-Sigma certified or willing to obtain certification preferred.
- Must possess excellent verbal written communication skills, as well as presentation, organizational skills.
- Knowledge of machining, metals and plastics processing and fabrication, and product assembly in the medical device industry.
- Ability to interface with customers, problem solve and drive solutions to meet customer requirements.
- Strong communicator with internal and external customers in all areas of the business: written and verbal (one-on-one and group).
- Rational thinker: good business judgment and ethics.
- Entrepreneurial attitude and mindset combined with the appropriate process orientation, focus and willing to embrace change. Self-motivated with a sense of urgency and accountability. Energetic and hardworking.
- High level of intellectual curiosity combined with strong problem solving and analytical skills. Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions.
Accellent is an Equal Opportunity/Affirmative Action employer and we value diversity in our workforce. As such we provide equal opportunity for all applicants without regard to race, religion, gender, national origin, age, marital status, veteran status, or disability. To learn more about Accellent and our career opportunities, please visit us at www.accellent.com
Accellent is an Equal Opportunity Affirmative Action employer and we value diversity in our workforce. As such we provide equal opportunity for all applicants without regard to race, religion, gender, national origin, age, marital status, veteran status, or disability. To learn more about Accellent and our career opportunities, please visit us at www.accellent.com
Submitting a resume online at a job site could cause valuable screening information to be missed.
Please apply directly at:
http://hostedjobs.openhire.com/epostings/jobs/submit.cfm?fuseaction=dspjobjobid=1997company_id=16184jobboardid=24
We are an Equal Opportunity Employer
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