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Experienced Quality Engineer, or QA Engineer

A job at Full time
Professional Level Professional experienced
We are looking for As of now
Location  Rochester, NY

In a regulated medical device manufacturing environment, manages the effective implementation of key quality systems to meet or exceed established metrics, quality objectives, regulatory requirements, and business goals. Supervises personnel responsible for incoming and final inspection as well as batch records (DHR) review. Serves as a key resource during internal and third party quality system audits.

Experienced Quality Engineer, or QA Engineer

Where we need you

Applies a strong knowledge of US FDA regulations and ISO 13485 requirements to the effective implementation of key operational quality system processes such as CAPA, Supplier Corrective Actions, Complaint Handling, NC Material Tracking and Disposition, DHR Review and Records Management, Work Environment, and Contamination Control.

Monitors key quality system metrics and interacts with owners of open items to ensure the timely completion of quality system activities according to the requirements of QMS procedures.

Provides training and direction related to quality systems to other associates.

Owns and manages change and improvement projects and corrective action activities in their area of responsibility.

Acts as a resource to lead or guide improvement and corrective action teams throughout the organization.

Tabulates, analyzes, and reports quality system metrics used in operational management and quality system processes such as Internal Audit and Management Review.

Manages records retention activities and directs the disposition of records according the approved procedures.

Develops curriculum and provides a portion of introductory training in Good Manufacturing Practices to new employees during orientation. Manages test development and administration of the annual GMP retraining and testing activities.

Serves as one of the primary resources during internal and third party audits either by directly interfacing with auditors or regulators or organizing “back room” activities.

Serves as the primary reviewer of outgoing Certificates of Compliance and associated data.

May serve as backup reviewer for DHR reviews.

How to convince us

Required Skills/Abilities: Bachelor’s degree in engineering or equivalent discipline or equivalent work experience Minimum 5 years in a manufacturing environment preferred (work or school) Strong knowledge of relevant software, quality assurance methods, tools and quality manufacturing processes Math skills Communication skills Knowledge of the organization’s product Attention to detail Analysis, critical thinking and problem-solving skills Interpersonal skills Ability to handle stress

Preferred Experiences: Medical Device industry experience. ASQ Certified Quality Engineer, Six Sigma Black Belt. Risk Management Principles. Demonstrated knowledge of compliance to ISO 13485 and FDA 21CFR 820.

What we offer

401(k) 401(k) matching/ Dental insurance/ Flexible spending account /Health insurance/ Life insurance /Paid time off /Retirement plan /Tuition reimbursement/ Vision insurance

Roechling Medical Rochester is part of the Medical Division within The Röchling Group. With an expertise in contract manufacturing, our in-house product design and mold making, accelerated tooling, and strong up-front engineering allows us to control and support programs at all levels. From part inception through part production and final assembly, Röchling Medical Rochester offers world-class quality, delivery, and price. Our focus on surgical, laboratory, and diagnostic devices delivers precise and well-engineered medical products for our customers.

Roechling Medical Rochester (RMR) is an Equal Opportunity Employer. RMR does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

In the Medical division, you will work with our customers to make pioneering contributions to disease prevention and health restoration worldwide. We offer a wide selection of custom-tailored components through to complete systems.

The Röchling Group has been shaping industry. Worldwide. For more than 200 years. We transform the lives of people every day with our customized plastics: they reduce the weight of cars, make medication packaging more secure and improve industrial applications. Our workforce of around 11,250 people is located in the places where our customers are – in more than 90 locations in 25 countries.

Jeanne Covert
Human Resources
+1 585 254 2000 ext 228

Röchling Medical Rochester
Holleder Technology Park, 999 Ridgeway Ave.
14615 Rochester, NY
United States

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