News

 General Information:

Company: Sontec Instruments, Centennial, CO http://www.sontecinstruments.com/

Location: 7248 S. Tucson Way, Centennial CO,

Hiring: Quality Control and Regulatory Specialist

Overview

• Quality Control and Regulatory specialist needed for a small surgical instrument company in East Centennial selling class 1 and class 2 instruments both domestically and abroad.
• This is a part-time contract position that allows for flexible weekly office hours, while also coordinating with our senior FDA analyst, in order to make sure all documents and procedures are up to date.
• Hours will increase and decrease as needed but it is anticipated that 15-20 hours a week will be needed on average.

The ideal candidate will possess the following:

• Working knowledge of FDA regulations, ISO 13845 and CE that specifically pertain to surgical and CFG’s.
• Working knowledge of device classification and listing within the surgical instrument and medical devices and surgical instruments and the ability to research new shipping areas as needed.
• The willingness and ability to maintain a strict quality calendar of meetings and internal audits to comply with FDA and ISO quality standards.
• The willingness and ability to complete all paperwork, spreadsheets and documentation necessary to keep all systems up to date on a weekly basis and submit reports to the VP of Operations monthly.

Please reply with your resume and salary requirements to: dscanlan@sontecinstruments.com

General Information:

Company: Rocky Mountain Poison and Drug Centers, Denver, CO

Location: 990 Bannock Street, Denver CO,

Hiring: Pharmacovigilance Program Manager

Description:

• Under minimal supervision, provides process ownership primarily related to post-market surveillance and drug safety.
• The successful candidate will be involved in the development and execution of pharmacovigilance processes, reports and business initiative planning.
• Responsibilities include management of client relationships, business and regulatory requirements, process management, strategic planning and staff supervision.
• Additional duties may include process improvement and general drug information research and special projects. Position requires experience with FDA/EU regulatory requirements, quality assurance, MedDRA, case processing and reporting.

Education & Experience

• Master’s Degree within the appropriate related field of study or equivalent experience required, or equivalent combination of education and work experience.
• Professional certification preferred.
• 5-7 years related experience preferred

Knowledge, Skills & Abilities:

• Excellent interpersonal and supervisory skills, strong organizational skills, and ability to assist with the management of multiple projects.
• Ability to demonstrate excellent work with minimal supervision, ability to prioritize tasks, ensure quality of work and regulatory compliance, and apply best practices for pharmacovigilance.

For more information and/or to apply please contact:

• Jim Booth – Recruiter
• Rocky Mountain Poison and Drug Center
• Phone: 303-389-1316
• email: jim.booth@RMPDC.org

General Information:

• Company: Covidien, Boulder, CO
• Location: Covidien, 5920 Longbow Dr, Boulder, CO 80301
• Hiring: Sr Software Design Quality Engineer
• Job ID Number: 140003KA

Overview Information

Via Covidien Job ID Number 140003KA web page

Job Description

• Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients.
• The Senior Software Design Quality Engineerensures that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.
• Provide leadership, oversight and training to division manufacturing plants forsoftware design quality. Mentor design teams on quality systems and requirements.

What is the work you will be doing?

• Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
• Promote a structured software development process. Assure that control is maintained for in-house and outsourced software development.
• Ensure compliance with internal and external procedures and regulations.
• Participate in review of requirements, architecture, design, code and other work products with a focus on patient safety and device quality, testability, manufacturability and serviceability.

Required: experiences or skills

• 5+ years of software design quality / compliance engineering experience or equivalent
• Working knowledge of C++, the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
• Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and knowledge of how these are applied in the software development lifecycle
• Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products

Preferred: experiences or skills

• Understanding of Object Oriented programming techniques
• Working knowledge of Unified Model Language (UML)
• ASQ CQE, CRE or CSQE certification
• Strong familiarity with regulatory requirements (e.g. ISO 62304, ISO 13485, 21 CFR Part 11, 21 CFR 820, ISO 14971).
• Experience in risk evaluation techniques, such as PRA (Product Risk Assessment), FMEA & fault tree analysis.
• Familiar with reliability analysis and test methods, including HALT and HASS.

For more information and to apply contact Galit Dana, Lead Sourcing Specialist at Covidien

• Via email: galit.dana@covidien.com
• Via Linked-in: http://www.linkedin.com/pub/galit-dana/20/61a/738

or visit Covidien Job ID Number: 140003KA web page

General Information:

Company: a Beverage Industry company

Hiring: Plant Manager-Food via The Kulwicki Group

Summary: Rapidly growing, multi-plant food processing company seeking an experienced Plant Manager for their plant in Maryland

Detail Information:

The Plant Manager’s role will:

• Be responsible for overall plant operations for a state-of-the-art, non-union, 24/7 food processing facility
• Develop, implement and maintain processes improvements to reduce costs
• Develop plant budget and capital plans
• Direct plant Safety programs to assure policy and procedure compliance

Background Profile:

• Experience as a Plant Manager in a food / beverage processing plant
• Bachelor’s degree
• Lean Manufacturing / Continuous Improvement experience
• Proven success at leading change and reducing costs

Company Offers:

• Competitive base salary + bonus + strong benefits + relocation assistance

For more information and to apply contact

• Phil Kulwicki, President/Recruitment for the Food Industry, The Kulwicki Group
• via email: pmk@wi.rr.com
• Via Linked-in: http://www.linkedin.com/pub/phil-kulwicki/7/9b9/300

or ZipRecruiter job posted web page https://www.ziprecruiter.com/job/Plant-Manager-Food-Beverage-Industry/b8b5cdf6/

General Information:

Company: Synergy Health AST, Denver, CO

Location: Synergy Health, 6750 East 46th Avenue Drive, Suite 100, Denver, CO 80216

Overview Information:

• Hiring: Director of Quality Assurance and Regulatory Affairs
• via job description web page: https://synergyhealthplc.applicantpro.com/jobs/138511.html

ESSENTIAL FUNCTIONS:

• Establishes procedures for maintaining high standards of service, quality, reliability, and safety.
• Determine and enforce – through functional groups – quality and regulatory requirements in accordance with company needs, based on current regulations and state-of-the-art product development.
• Organize and promote companywide quality and service improvement efforts.

SUPERVISORY RESPONSIBILITIES:

• Via matrix management, co-supervise the Quality Assurance Department of Synergy Health consisting of Service Facility Quality Assurance managers
• Directly supervises the AST Corporate Quality Manager and Software Quality Engineer.

EXPERIENCE:

• A minimum of 7 years of related experience with FDA registered companies is desired, with at least 2 years in quality management role.

KNOWLEDGE, SKILLS, ABILITIES:

• Excellent verbal, written communication and mathematical skills required. Must be a team player.
• Strong computer skills required, excellent working knowledge of MS Word, MS Excel.
• Experience with Synergy Health’s current operating software preferred.
• Ability to present and execute regulatory and quality programs working closely with senior management and facility personnel.

For more information and to apply see web page:  https://synergyhealthplc.applicantpro.com/jobs/138511.html

General Information:

• Company: Surgical Technologies Division, Medtronic, Louisville, CO
• Location: Surgical Technologies Division, Medtronic, 826 Coal Creek Cir, Louisville, CO 80027

 

Hiring: Sr Quality Engineer Failure Analysis (STQRA) – Job id 93489

Position Description

• Provide failure investigation engineering support of Navigation systems throughout the product life cycle.
• Participate in the product assurance of design, manufacturing, and testing of systems and components with an emphasis on electronic, mechanical, and electro-mechanical products.
• Analyze field returns data for product and design improvement opportunity

For more information and to apply for see Job id 93489 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

• Office phone: +1 817-788-7528
• Mobile phone: +1 817-996-2317
• Email: wendy.hawker@medtronic.com
• US mail: Surgical Technologies, Human Resources, 4620 N Beach, Fort Worth, TX 76137

General Information:

• Company: Surgical Technologies Division, Medtronic, Louisville, CO
• Location: Surgical Technologies Division, Medtronic, 826 Coal Creek Cir, Louisville, CO 80027

 

Hiring: Quality Systems Director Navigation & Imaging (STQRA) – Job id 93590

Position Description

• The Quality Systems Director is responsible for developing, implementing and driving the quality system for the Louisville, CO facility and providing Quality Systems leadership support to the Imaging facilities in Littleton, MA and Yokneam, Israel.
• This role is responsible for developing common/harmonized QS procedures across 3 sites (where appropriate) as well as working across the Surgical Technologies sector to ensure common/harmonized QS procedures between the sector and the Louisville, Littleton, and Israel sites.
• The Quality Systems Director will lead the quality system function to ensure quality system development and compliance with FDA’s Quality System Regulation, ISO 13485, MDD, MHLW and all other applicable requirements.
• Additionally, this position will develop, establish and maintain effective quality system programs, architecture, content, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company standards necessary to maintain lasting consumer satisfaction.
• This position requires strong leadership, communication, collaboration and relationship building cross-functionally within the three Navigation & Imaging sites and across the Surgical Technologies sector.

For more information and to apply for see Job id 93438 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

• Office phone: +1 817-788-7528
• Mobile phone: +1 817-996-2317
• Email: wendy.hawker@medtronic.com
• US mail: Surgical Technologies, Human Resources, 4620 N Beach, Fort Worth, TX 7613

General Information:

• Company: Surgical Technologies Division, Medtronic, Louisville, CO
• Location: Surgical Technologies Division, Medtronic, 826 Coal Creek Cir, Louisville, CO 80027

Hiring: Sr Quality Engineer(STQRA) – Job id 93438

Position Description

• Assure the timely, accurate and independent evaluation of product performance and compliance to safety and regulatory requirements prior to market release of new products.
• Support design changes and perform quality analysis of released products.
• Collaborate with suppliers to ensure product specifications are met.
• Recommend, plan and lead corrective and preventive actions for continuous improvement.
• May specialize in areas such as design quality assurance, sustaining quality assurance, incoming quality assurance, production and inventory control, process validations, and/or supplier management.

For more information and to apply for see Job id 93438 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

• Office phone: +1 817-788-7528
• Mobile phone: +1 817-996-2317
• Email: wendy.hawker@medtronic.com
• US mail: Surgical Technologies, Human Resources, 4620 N Beach, Fort Worth, TX 76137

General Information:

• Company: Surgical Technologies Division, Medtronic, Louisville, CO
• Location: Surgical Technologies Division, Medtronic, 826 Coal Creek Cir, Louisville, CO 80027

Hiring: Sr Software Quality Engr (STQRA) – Job id 92212

Position Description

• Works with minimal guidance to support the design, development, test, and market release of software used in both surgical navigation applications and other medical devices.
• Contribute to the processes and tools used to create and test software applications.
• Develop and assess the quality programs and systems of Medtronic Navigation to applicable standards.

For more information and to apply for see Job id 92212 web page

Visit Medtronic Quality Quality and Regulatory Jobs web page for other similar positions

Also contact Medtronic’s Talent Acquisition Specialist, Wendy Hawker

• Office phone: +1 817-788-7528
• Mobile phone: +1 817-996-2317
• Email: wendy.hawker@medtronic.com
• US mail: Surgical Technologies, Human Resources, 4620 N Beach, Fort Worth, TX 76137