What are the responsibilities and job description for the Sr Supplier Qual Engineer position at Planet Pharma?
Pay 40-50/h depending on experience
Top 3 things you are looking for in a candidate’s experience (please be specific):
Medical Device Experience
Electrical / Mechanical background
Component / Product Qualification – Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.
Education Required: Bachelors in Engineering.
Years’ Experience Required: 3-6 years.
A Day In The Life
Medical Device Experience
Electrical / Mechanical background
Component / Product Qualification – Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.
Education Required: Bachelors in Engineering.
Years’ Experience Required: 3-6 years.
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes. 40 hours.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Fully onsite.
What is your timeline for scheduling interviews? Interviews can start as early as 21-Sep.
What product line will this person support? Sphere-9 Catheter Production in Billerica, MA.
Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products. Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements. Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products. Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor.Works independently under limited supervision to determine and develop approach to solutions.Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.Makes improvements of processes, systems or products to enhance performance of the job area.Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors.Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.May have practical knowledge of project management.Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.
Top 3 things you are looking for in a candidate’s experience (please be specific):
Medical Device Experience
Electrical / Mechanical background
Component / Product Qualification – Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.
Education Required: Bachelors in Engineering.
Years’ Experience Required: 3-6 years.
A Day In The Life
- Support and lead Supplier Quality activities per company requirements.
- Support and lead Product Qualification activities ensuring suppliers are capable of delivering quality products, materials, and services.
- Assess and qualifies suppliers according to company requirements.
- Monitors products through the manufacturing cycle and resolves supplier-related problems before they occur.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
- Lead and develop the Product Acceptance Strategy for incoming inspection and associated test method validation for all internal Test Methods.
- Lead and support Supplier Change Requests.
- Lead Supplier Related NCMRs through disposition, corrective and preventative actions with Supplier.
- Assist in Approved Supplier List (ASL) Activities
- Provide routine communication and updates to leadership regarding supplier activities and performance.
Medical Device Experience
Electrical / Mechanical background
Component / Product Qualification – Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.
Education Required: Bachelors in Engineering.
Years’ Experience Required: 3-6 years.
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes. 40 hours.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Fully onsite.
What is your timeline for scheduling interviews? Interviews can start as early as 21-Sep.
What product line will this person support? Sphere-9 Catheter Production in Billerica, MA.
Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products. Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements. Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products. Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor.Works independently under limited supervision to determine and develop approach to solutions.Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.Makes improvements of processes, systems or products to enhance performance of the job area.Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors.Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.May have practical knowledge of project management.Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.
- 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.