Primary Talent Partners
Primary Talent Partners has a new contract opening for a
Sr Quality Engineer
with our medical device client in Lafayette, CO. This is an 11-month contract with a potential for extension.
Pay:
$55.00 - $65.00/hr ; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.
Description: The Senior Quality Engineer position on the team supports new product development for Surgical Instruments. In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of mechanical and electro-mechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:
Actively participate in product development cycle by reviewing mechanical/electro-mechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc. Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required. Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses. Assisting with projects and assuring proper and consistent implementation of the quality engineering tools. Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. Embedded Responsibilities:
Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills. BASIC QUALIFICATIONS
EDUCATION REQUIRED:
B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality Preferred:
M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality
YEARS OF EXPERIENCE:
Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline) SPECIALIZED SKILLS OR EXPERIENCE:
Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external. Experience in a regulated industry Experience with Minitab or similar statistical analysis tools Experience with Risk Management Tools Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships. Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills). High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning. NICE TO HAVE:
ASQ Certified Quality Engineering (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements Understanding of software and hardware interface
Top 3 technical skills that are required for the role: Risk Management (Hazard Analysis, DFMEA, UFMEA) Design Verification Authoring and Execution General NPD QE skillset. (Change control, CAPA, Iso 13485 understanding)
PHYSICAL JOB REQUIREMENTS
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
#LI-PTP
Sr Quality Engineer
with our medical device client in Lafayette, CO. This is an 11-month contract with a potential for extension.
Pay:
$55.00 - $65.00/hr ; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.
Description: The Senior Quality Engineer position on the team supports new product development for Surgical Instruments. In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of mechanical and electro-mechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED:
Actively participate in product development cycle by reviewing mechanical/electro-mechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc. Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required. Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses. Assisting with projects and assuring proper and consistent implementation of the quality engineering tools. Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. Embedded Responsibilities:
Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills. BASIC QUALIFICATIONS
EDUCATION REQUIRED:
B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality Preferred:
M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality
YEARS OF EXPERIENCE:
Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline) SPECIALIZED SKILLS OR EXPERIENCE:
Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external. Experience in a regulated industry Experience with Minitab or similar statistical analysis tools Experience with Risk Management Tools Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships. Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills). High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning. NICE TO HAVE:
ASQ Certified Quality Engineering (CQE) Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements Understanding of software and hardware interface
Top 3 technical skills that are required for the role: Risk Management (Hazard Analysis, DFMEA, UFMEA) Design Verification Authoring and Execution General NPD QE skillset. (Change control, CAPA, Iso 13485 understanding)
PHYSICAL JOB REQUIREMENTS
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
#LI-PTP