Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future.
The Endoscopy Strategic Business Unit was established to provide innovative products for gastrointestinal endoscopy. By working closely with prominent gastroenterologists, Cook Endoscopy has become a worldwide leader in the design, development and manufacture of devices used in gastrointestinal endoscopy, bronchoscopy, and surgery, in the treatment of esophageal, stomach, pancreatic, liver and colon disorders. Key product lines include but are not limited to sphincterotomes, wire guides, biliary stents, forceps, needles, cytology brushes, multi-band ligators, Percutaneous Endoscopic Gastrostomy systems (PEGs) and polypectomy snares.
The primary purpose of this position is to assist the Quality Engineering Manager through development, implementation and review of quality engineering activities, including qualification, verification and validation, complaint processing, quality system investigations and product quality issues.
- Review and approve documentation generated by the Engineering department. This may include but is not limited to review of design input requirements, verification protocols and reports, design validation protocols and reports, risk documentation, and process validation protocol and reports.
- Performing investigations for field complaints. This task includes examining returned product, establishing failure modes, obtaining associated hazards, evaluating data for trends and obtaining associated design and process controls to conclude recommended actions based on risk.
- Oversee and sponsor CAPA's assigned to personnel throughout the company. This will include review and approval of root cause assessment, review and approval of long term actions, review of testing performed, driving timelines and overall management of the CAPA to ensure action is timely and effective. As the Quality Engineering sponsor of the CAPA, the expectation is that the Quality Engineer will be part fo the solution to the issue. This also includes management of supplier CAPA's.
- Lead, support and implement Quality type projects.
- Perform other duties as needed
PHYSICAL AND ENVIRONMENTAL REQUIREMENTS:
- 4 year college degree in a technical discipline or equivalent work experience.
- Proven written and verbal communication skills.
- Basic knowledge of statistical process control techniques.
- Detail oriented.
- Excellent organizational skills.
- Proven problem solving skills.
- Good computer skills including experience with word processing and spreadsheet software.
- Basic understanding of statistics.
- Must be able to perform essential functions of job, with or without reasonable accommodations.
- Work is performed in a normal working environment with majority of the day spent sitting and moving around various departments.
- Complaint evaluation work requires protective glasses and gloves when working with biologically contaminated returned products.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
- Base Salary
- Teamwork bonus
- 401(k) retirement savings plan with company match
- Profit sharing
- Medical, dental, and vision
- Life insurance
- Paid time off
- Flexible spending account
- Educational assistance/reimbursement
Cook Medical - 2 years ago
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...