- Oversee the team responsible for disposition of Nonconforming Product and investigation with suppliers including Supplier Corrective Actions. Responsible for data trending associated with nonconforming product.
- Assist with day-to-day efforts of new product development in design control including the management and implementation of P28 Design History Files, Risk Management Files and Device Master Records.
- Build relationships with production suppliers and quality counterparts to ensure continued delivery of product that meets specifications.
- Lead the quality portions of Supplier Quarterly Business Reviews and oversee the creation of quality metrics within the supplier score card.
- Responsible for product investigations resulting from complaints.
- In conjunction with the Manager of Quality Design: Provide design quality guidance and oversight of supplier production meetings for new products and design changes. Work directly with P28 Product Development to support the launch of new product and design changes pertaining to line extensions, design changes, or small scope systems.
- Manages Quality System management responsibility including all requirements as identified in 21 CFR 820, ISO 13485: 2016, EU MDR and ISO
- Lead employees to meet the departmental and organizational expectations for productivity, quality, continuous improvement and goal accomplishment. Coach, mentor and develop staff, including recruitment and onboarding, performance management and career development.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
- Other duties as assigned.
-
Quality Manager
2 days ago
Nexus Solutions Englewood, United StatesJOB DESCRIPTION · We - the company Enders Konstruktion GmbH - are one of the largest engineering companies in the general mechanical and plant engineering industry and have been successful in the market for over 30 years. For national and international projects, we are continuous ...
-
Quality Manager
3 weeks ago
Plastic Molding Technology Inc Englewood, United StatesJob Description · Job Description · Company Description: · Plastic Molding Technology leverages its three strategic locations to provide engineering expertise and full-service solutions within our core capabilities of injection molding, thermoforming and extrusion. Our Centers ...
-
Quality Manager
1 week ago
Plastic Molding Technology LLC Englewood, United StatesJob Description · Job DescriptionCompany Description: · Plastic Molding Technology leverages its three strategic locations to provide engineering expertise and full-service solutions within our core capabilities of injection molding, thermoforming and extrusion. Our Centers of E ...
-
Quality Continuous Improvement Manager
3 weeks ago
H.B. Fuller Aurora, United StatesAs the largest pureplay adhesives company in the world, H.B. Fuller's (NYSE: FUL) innovative, functional coatings, adhesives and sealants enhance the quality, safety and performance of products people use every day. Founded in 1887, with 2023 revenue of $3.5 billion, our mission ...
-
Quality Assurance Manager
2 weeks ago
Enscicon Corporation Englewood, United StatesQA Manager-Electric Utility · Seeking a QA Manager with a utilities background to create, implement and monitor our corporate Quality Assurance Program based out of the Denver office. · We support the federal government, military institutions, municipalities, and major utilitie ...
-
Quality Management Employee
2 days ago
Sapphire Solutions Welby, United StatesWe are Trio Personnel Management - your regional staffing agency. Our entire management team, as well as our employees, have extensive experience in temporary staffing, recruitment, sales, customer service, recruiting, and employee care, and approach their work with a strong serv ...
-
Quality Management Officer
2 days ago
Galaxy Group Indian Hills, United StatesIndian Hills is a technology company that develops innovative technologies and services for sustainable and connected mobility of people and goods. Founded in 1871, the company offers safe, efficient, intelligent, and affordable solutions for vehicles, machinery, traffic, and tra ...
-
Quality Assurance and Safety Manager
3 weeks ago
Vidya Brands Group LLC Westminster, United StatesSeaboard Folding Box is a full-service provider of custom structural packaging with extensive design, pre-press, printing and finishing capabilities. Our company has a 60+ year track record making folding cartons, and our highly experienced workforce allows us to deliver quick tu ...
-
Quality Control Manager
2 weeks ago
ECC Littleton, United States· ECC is seeking candidates for a Quality Control Manager position. This position is primarily responsible for verifying compliance with quality requirements on ECC projects, focusing on our disaster recovery and environmental remediation projects, as defined by Company standard ...
-
Manager, Supplier Quality
3 weeks ago
Insight Global Littleton, United StatesInsight Global is looking for a Manager, Supplier Quality for a medical device company in Colorado. The Manager will sit out of the clients Littleton manufacturing plant, requiring five days onsite a week, managing three junior supplier quality engineers. The Manager can expect t ...
-
Quality Engineering Manager
1 week ago
Lockheed Martin Corporation Littleton, United StatesThe Deep Space Exploration (DSE) Program Quality Manager is responsible for leading a team with oversight over multiple missions exploring deep space – Venus, Mars, Jupiter, and beyond. The leader in this position will inspire a team of engineers to execute to a strategic plan in ...
-
Quality Assurance Manager
3 weeks ago
Enscicon Corporation Greenwood Village, United StatesQA Manager-Electric Utility · Seeking a · QA Manager with a utilities background · to create, implement and monitor our corporate Quality Assurance Program based out of the Denver office. · We support the federal government, military institutions, municipalities, and major util ...
-
Utility Quality Manager, Infrastructure
1 week ago
JHL CONSTRUCTORS INC Englewood, United StatesJob Description · Job DescriptionSalary: $75K - $85K · Reports to: Infrastructure General Superintendent · FLSA: Exempt · JOB SUMMARY: · The Utility Quality Manager is responsible for all aspects of utility quality including visual inspections, product data review, backfill/co ...
-
Utility Quality Manager, Infrastructure
2 weeks ago
JHL Constructors Inc Englewood, United StatesJob Description · Job DescriptionThe Utility Quality Manager is responsible for all aspects of utility quality including visual inspections, product data review, backfill/compaction, attending preconstruction meetings, creating quality control protocols, interacting with JHL util ...
-
Space Quality Assurance Manager
1 week ago
General Atomics and Affiliated Companies Englewood, United StatesGeneral Atomics Electromagnetic Systems (GA-EMS) designs and manufactures first-of-a-kind electromagnetic and electric power generation systems. GA-EMS' expanding portfolio of specialized products and integrated system solutions support critical fleet, space systems and satellite ...
-
Quality Assurance Manager
1 week ago
Novel Tech Services Greenwood Village, United StatesJob Description · Job DescriptionFrom $90,000.00 to $110,000.00/yr · We are seeking a strong QA Manager with a utilities background to create, implement and monitor our corporate Quality Assurance Program based out of the Denver office. We have built a reputation as an innovativ ...
-
Quality Management Development Associate
2 weeks ago
PHM Brands Dawn, United StatesQUALITY MANAGEMENT DEVELOPMENT ASSOCIATE RESPONSIBILITIES: · Implement and monitor programs and standards to ensure safe and efficient laboratory activities, the production of quality and safe food products that comply with government regulations and customer requirements. Work ...
-
Quality Manager
2 weeks ago
FATHOM Denver, CO, US, United StatesFathom is one of the largest digital manufacturing platforms offering on-demand manufacturing in North America. With more than 90 large-platform industrial-grade 3D printing machines and a national footprint with more than 450,000 square feet of manufacturing capacity across 12 f ...
-
Quality Manager
1 hour ago
FATHOM denver, United StatesFathom is one of the largest digital manufacturing platforms offering on-demand manufacturing in North America. With more than 90 large-platform industrial-grade 3D printing machines and a national footprint with more than 500,000 square feet of manufacturing capacity across 10 f ...
-
Quality Manager
6 days ago
INTERCONNECT WIRING LLP, CHRIS BETTINGER- JOHN ASHOUR - Denver, United StatesINTERCONNECT WIRING LLP, CHRIS BETTINGER- JOHN ASHOUR - · Quality Manager · Fort Worth , · Texas · Apply Now · We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, ...
Associate Manager of Quality - Englewood, United States - Paragon 28
3 weeks ago
Description
Paragon 28's growth continues and we're looking for more great employees Now is your chance to join this public company dedicated to improving a patient's quality of life with the treatment of the most challenging foot and ankle conditions We are currently looking to fill the position of Associate Manager of Quality - Design with a starting range of $88,600 - $121,000/year, dependent upon experience, education, and skills. This position may have the opportunity for occasional work from home.
The Associate Manager of Quality, Design is responsible for ensuring the daily compliance of P28's quality management system within the quality team, including compliance to regulations and standards such as 21 CFR 820 and ISO 13485:2016 with a focus on Design Controls, Risk Management and Nonconforming product. This position is also responsible for the management of direct reports within this team.
Key Responsibilities
Work Environment
This job operates in a distribution office environment. This role routinely uses standard office equipment such as computers, phones and copy machines.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee is required to have close visual acuity to perform activities such as inspecting small parts and viewing computer terminal. The employee is frequently required to move about the facility. The employee may be required to lift up-to 15 lbs. by themselves.
Position Type/Expected Hours of Work
This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager.
Travel
Less than 10% of overnight travel; potential for either domestic or international travel.
